Name: Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke (Video) | JoVE Journal
Uploaded: 2025-06-06T13:10:00.000+00:00
Duration: 8 min 53 s
Description: Learn how high-definition tDCS combined with computerized cognitive stimulation addresses hemispatial neglect in stroke patients. This protocol demonstrates feasibility for enhancing cognitive rehabilitation outcomes.

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5 minutes

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Hemispatial neglect is a frequent cognitive consequence of stroke, and when it persists, it tends to negatively impact the effectiveness of the rehabilitation process. The efficacy and efficiency of the available therapeutic approaches can be improved by including noninvasive brain stimulation techniques in neurorehabilitation, looking for a synergistic effect 40,41. Thus, by means of tDCS, we can boost the effectiveness of conventional intervention, achieving greater recovery, shorter rehabilitation times, and better functional outcomes in the rehabilitation of the stroke patient compared with conventional intervention in isolation. Research on the potential of tDCS in neurological and psychiatric disorders has exponentially increased in the last decade42,43,44,45,46,47,48,49.
In addition, the cost of tDCS is affordable, and the device is portable, which makes it highly scalable, allowing its application in both outpatient clinics and hospital settings, with the required professional training50.
We have found an improvement after the treatment in four of the thirteen tests administered (bells test, cancellation test, line bisection, visual motor-free perception test). The tests where we have observed these positive changes are related to the performance associated with hemispatial neglect. On the other hand, stabilization has been observed in the performance of some tests related to general cognitive performance, attentional processes and/or working memory (MMSE, drawings, CBS). A reduction has been observed in the performance of some other tasks (BTA, Faces, direct and inverse digits).
Regarding functional scales, there was evidence of improvement, reported by the primary caregiver and assessed by the Barthel Index scale. The CBS functional scale, which is directly related to the impact of neglect on daily life, was also administered, and, in this case, no change was evidenced, remaining stable with respect to the previous assessment. In this study, we found the benefits of the combined treatment for some cognitive domains but not for others. These findings are consistent with the idea that the treatment could be more beneficial for certain attentional domains51,52,53,54,55,56,57. Some studies show how specific tDCS protocols induce lasting alterations in cortical excitability and activity58. In order to be able to analyze the maintenance of the changes beyond a week, it would be advisable to carry out a new assessment after a longer period of time53,54,55,56,57.
High-definition or high-resolution tDCS, used in this study, is a technically enhanced version of tDCS that allows increasing the focality of the stimulation by using a ring of return electrodes around an anode or a cathode to increase or decrease, respectively, the cortical excitability in a much more focal way59. Based on this high focality and the previous tolerability and effects of HD-tDCS study by Borckardt et al.60, the use of HD-tDCS has increased in recent years.
Modeling studies indicate that this electrode configuration generates the highest electric field (EF) intensity beneath the target electrode, with the brain current flow constrained by the radius of the 4 x 1 ring setup and, thus, a larger electric field at the selected target compared to conventional electrode placement60,61,62. The return electrodes contribute to isolating the targeted area, allowing for more focused brain stimulation and producing longer-lasting effects than conventional tDCS63.
In addition, according to some studies, HD-tDCS has longer-lasting effects. Lately, clinical research has been paying attention to this protocol. To our knowledge, only six studies have been conducted with HD-tDCS in neurological diseases, three randomized control trials, two open-label reports, and one case report (refer to the review49).
Although there is no total consensus on the anatomical areas related to hemispatial neglect, there seems to be some agreement on some specific areas. The posterior parietal cortex seems to be the key area of the alteration64,65,66, and within this area, the angular gyrus64,65,67,68,69, the intraparietal sulcus64,69,70, the temporoparietal junction69,71and the supramarginal gyrus65,72,73,74.
Given that the benefit of HD-tDCS compared to conventional tDCS is increasing the precision in the stimulation target and based on the knowledge of a precise location for the presence of hemispatial neglect, we can expect to obtain greater benefits from focal stimulation compared to more general or diffuse stimulation. Meanwhile, the most used configuration in neurology studies is 4 x 1 montage75,76,77,78,79. In our study, we used a 7 x 1 configuration with the aim of increasing the focality of the stimulation even more, being the first study using this montage in clinical rehabilitation of neglect. Therefore, further research in this and other clinical conditions must be conducted to determine the superiority or efficacy of this HD-tDCS montage over other HD montage and conventional tDCS.
Regarding intensity, 2 mA is applied in this protocol, as in most of the studies with tDCS, no matter what montage or configuration is used. It would be interesting to compare the same protocol with lower and higher intensities in further studies to figure out the effect of different applied intensities.
Some useful recommendations regarding safety and technical troubleshooting must be taken into consideration with the current protocol. In every patient, but especially in stroke patients, safety issues should be thoroughly assessed. Although tDCS in stroke patients is safe and well tolerated80, the patients and their families sometimes have doubts about it. Thus, comprehensible information should be handed in advance and discussed with the patient and relatives, ensuring that they understand the procedure and can abandon the protocol whenever they want to.
On the other hand, in this protocol, the exact location of the lesion has been considered and recorded as we are willing to compare the effect of the protocol on hemispatial neglect after cortical lesions (e.g., right middle cerebral artery)69 and after subcortical lesions (e.g., basal ganglia)81. In this context, it is crucial to assess the technique&#39;s efficacy in light of the heterogeneity in lesion locations. Specifically, we need to analyze the variations in effectiveness concerning cortical versus subcortical lesions.
Regarding the stroke phase, when applying the stimulation (acute, subacute, or chronic), it is important to know the moment in which the intervention could be most beneficial. In this study, we have used as an inclusion criterion 3 to 12 months since the injury (subacute phase). However, a previous systematic review focused on motor aspects after stroke, and results have shown improvements in chronic phases but not in the acute phase (within the first 3 days from the onset of symptoms)82. Further investigation is necessary to explore the benefits of tDCS on post-stroke cognitive alterations and to identify factors that predict its optimal effectiveness across various stages of recovery.
The current knowledge about HD-tDCS as a therapeutic approach in neurological diseases supports its tolerability and clinical efficacy. Besides, further randomized controlled research is needed to figure out the optimal parameters in each disease and each patient in order to establish the effectiveness of this noninvasive brain stimulation technique in neurological disorders and beyond.

Stroke is the most common cause of disability in the world in adults and the second cause of death after ischemic heart disease1. Most patients who have survived a stroke develop very heterogeneous clinical conditions and different degrees of disability. Between 55% and 75% of stroke patients have motor limitations that persist 6 months after the injury2. In addition to the physical consequences, cognitive alterations are very frequent3. These deficits negatively affect the performance of activities of daily living, limiting the functional independence and the quality of life of patients and relatives4,5. Hemispatial neglect is among the most common attentional impairments following a stroke, occurring in approximately 25% to 50% of cases6,7,8 and rising to as much as 80% in individuals with right-hemisphere strokes9,10.
Hemispatial neglect implies a difficulty in attending the contralateral hemifield to the injured area, being this inattention allocentric (omitting objects located in the left half of the space) or egocentric (patient does not attend to left parts of his/her own body). Functionally, neglect generates severe difficulties in the independence of the patient, both in basic (e.g., grooming, clothing, eating, etc.) and instrumental activities of daily living (e.g., money management, public transport, or independent walking). Moreover, the presence of this alteration has been associated with longer hospitalization and rehabilitation times, higher risk of falls, poor motor recovery, and lower probability of returning home after discharge from hospital11,12.
Several strategies have been implemented to treat hemispatial neglect. Within traditional rehabilitation approaches, we can distinguish the top-down and the bottom-up approaches. The main difference between them is the level of active participation and awareness of the person in tasks. Within these approaches, the most widely used procedures to date have been visual scanning training and prismatic adaptation, respectively13. Other rehabilitation techniques in hemispatial neglect with wide use central location, optokinetic, caloric, and vestibular stimulation, neck vibration, and pharmacological treatments13,14,15,16. However, these treatments have some limitations: the duration of their results is very limited, and they have low applicability in the acute or subacute phases because the severity of the patients in these phases interferes with their collaboration in the activities to be performed17.
Transcranial direct current stimulation (tDCS) is a noninvasive safe neuromodulation technique able to modify cortical activity by inducing a weak electric current into the brain that changes the cortical activity, and it can be used to complement neuropsychological rehabilitation for hemispatial neglect. tDCS modulates spontaneous neuronal activation in response to inputs from other brain areas. Furthermore, tDCS induces plastic synaptic changes that resemble long-term potentiation (LTP) or long-term depression (LTD) and even last beyond the duration of stimulation18.
By means of tDCS, cortical activity can be modulated by applying a very low-intensity electric current that flows from the anode to the cathode. tDCS modulates brain activity by influencing the threshold of the action potential, increasing or decreasing it, but without causing action potentials18. In general, the anode induces an increase in the excitability of the brain region on which it is located, while the cathode induces cortical inhibition. This technique does not have a high spatial resolution, but this limitation has been overcome by the appearance of new tDCS devices called multisite or high definition (HD- tDCS). These devices allow different electrode configurations, such as forming a cathodal ring around the anode (or vice versa) in order to increase or decrease cortical excitability in a specific brain area. The cathode ring acts in a similar way to the return electrodes, limiting the stimulation area; in this way, a more focal stimulation is achieved. tDCS has proven effective as a therapeutic approach for motor recovery after stroke19, and there is some scientific literature with promising results in the rehabilitation of hemispatial neglect20.
The most accepted hypothesis of hemispatial neglect argues that it could be explained based on the hemispheric rivalry model, proposed by Kinsbourne in 197721,22. According to this approach, in the basal state, both hemispheres are constantly inhibiting each other in a reciprocal manner; hemispatial neglect is caused by an imbalance between them. After an injury, the damaged hemisphere is not able to effectively inhibit the activity of the preserved hemisphere. This results in pathological hyperactivity of the healthy hemisphere due to the absence of inhibition exerted by the damaged one, which reduces, even more, the neural activity of the affected hemisphere because of the increased inhibition exerted over it23. Therefore, the dysfunction that underlies hemispatial neglect is caused by both hypoactivity of the damaged hemisphere and hyperactivity of the intact one24.
With this model as a theoretical background, different noninvasive brain stimulation strategies aimed to improve hemispatial neglect symptoms are proposed. These strategies are addressed to decrease the hyperactivity of the healthy hemisphere, increase the activity of the injured hemisphere, or a combination of both25,26.
Several studies have shown the potential of tDCS in reducing hemispatial neglect symptomatology by applying both anodal17,27,28,29 and cathodal17,29 tDCS in the injured or undamaged hemisphere, respectively, or a combination of both28,30,31,32. Despite promising results, more empirical evidence is needed to know the exact parameters of tDCS to achieve optimal results, which is essential to know if focal tDCS is more effective than conventional tDCS montages. To our knowledge, all the previous research has been developed using conventional tDCS, with the present study being the first to use HD-tDCS for hemispatial neglect rehabilitation.
Interventions based on noninvasive brain stimulation constitute a very promising clinical approach given the results up to date and the limited adverse effects according to different meta-analyses and reviews33,34,35,36,37. In addition, tDCS is a highly safe, portable, and low-cost technique, which is why its use has increased as a priority in clinical and research settings. Also, its easy assembly and portability allow the device to be used simultaneously with the performance of any other activity, such as physical, cognitive rehabilitation, or functional activities. Thus, more controlled, blinded, randomized studies with larger sample sizes are warranted to validate tDCS protocols that enhance the effects of conventional intervention approaches.

<table><tbody><tr><td>10 electrode cable</td><td>Neuroelectrics</td><td>NE017</td><td></td></tr><tr><td>Barthel Index</td><td>N/A</td><td></td><td>&amp;nbsp;Mahoney, F. I., Barthel, D. W. Functional evaluation: The Barthel Index. Md State Med J. 14, 61&amp;ndash;65 (1965).</td></tr><tr><td>Copy of drawings subtest</td><td>N/A</td><td>https://test-barcelona.com/es/tienda.html</td><td>J. Pe&amp;ntilde;a Casanova, Programa integrado de exploraci&amp;oacute;n neuropsicol&amp;oacute;gica: test Barcelona revisado?: TBR. Barcelona: Masson.</td></tr><tr><td>Curved Syrenge</td><td>Neuroelectrics</td><td>NE014</td><td></td></tr><tr><td>Electrode Gel</td><td>Neuroelectrics</td><td>NE016a</td><td></td></tr><tr><td>Line bisection test</td><td>N/A</td><td></td><td>Schenkenberg, T.,&amp;nbsp; Bradford, D. C.,&amp;nbsp; Ajax, E. T. Line bisection and unilateral visual neglect in patients with neurologic impairment. Neurology. 30 (5) 509&amp;ndash;517 (1980).</td></tr><tr><td>Mini-mental state examination (MMSE)</td><td>N/A</td><td></td><td>Folstein, M. F., Folstein, S. E., McHugh, P. R. &amp;ldquo;Mini-mental state&amp;rdquo;. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 12 (3) 189&amp;ndash;198 (1975).</td></tr><tr><td>Neoprene headcap</td><td>Neuroelectrics</td><td>NE019-M</td><td></td></tr><tr><td>Saline Solution</td><td>Neuroelectrics</td><td>NE033</td><td></td></tr><tr><td>Satrstim Necbox</td><td>Neuroelectrics</td><td>NE012</td><td></td></tr><tr><td>Starstim tES-EEG System</td><td>Neuroelectrics</td><td></td><td></td></tr><tr><td>Teastboard Cable</td><td>Neuroelectrics</td><td>NE039</td><td></td></tr><tr><td>Testboard Head</td><td>Neuroelectrics</td><td>NE038</td><td></td></tr><tr><td>The Bell Test</td><td>N/A</td><td>https://strokengine.ca/en/assessments/bells-test/</td><td>L. Gauthier, F. Deahault and Y. Joanette, The Bells Test: A quantitative and qualitative test for visual neglect (Vol. 11).</td></tr><tr><td>The Catherine Bergego Scale</td><td>N/A</td><td></td><td>Azouvi, P. et al.&amp;nbsp; Behavioral assessment of unilateral neglect: study of the psychometric properties of the Catherine Bergego Scale. Arch Phys Med Rehabil. 84 (1) 51&amp;ndash;57 (2003).</td></tr><tr><td>The motor-free visual perception test (MVPT)</td><td>N/A</td><td>https://www.wpspublish.com/mvpt-4-motor-free-visual-perception-test-4</td><td>Colarusso, R. P., Hammill, D.D. The Motor Free Visual Perception Test (MVPT-3). Navato, CA: Academic Therapy Publications (2003).&amp;nbsp;</td></tr><tr><td>USB Bluetooth Dongle</td><td>Neuroelectrics</td><td>NE031</td><td></td></tr><tr><td>USB charging Cable</td><td>Neuroelectrics</td><td>NE043</td><td></td></tr><tr><td>USB Power Adapter &amp;amp; Power Supply Plug</td><td>Neuroelectrics</td><td>NE013 &amp;amp; NE013a, NE013b, NE013c</td><td></td></tr><tr><td>USB Stick with Manuals &amp;amp; NIC SW</td><td>Neuroelectrics</td><td>NE015</td><td></td></tr></tbody></table>

randomized, triple-blind, and parallel-controlled trial of transcranial direct current stimulation for cognitive rehabilitation after stroke

Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke

Right hemisphere stroke frequently results in hemispatial neglect, a disabling condition that can significantly impede the recovery process. The chronic presence of neglect has been linked to poorer outcomes in both cognitive and motor domains. As an adjunct to conventional neuropsychological interventions, transcranial direct current stimulation (tDCS)-a noninvasive technique that modulates neural excitability through low-intensity electrical currents-has gained attention for its potential to enhance cortical plasticity and support functional improvement in affected individuals.
In this study, we propose a combined intervention protocol aimed at reducing symptoms of post-stroke hemispatial neglect. It consists of a cathodal tDCS protocol combined with a computerized neuropsychological rehabilitation program specifically designed for the rehabilitation of hemispatial neglect.
The neuromodulation strategy is to reduce the hyperactivation of the undamaged hemisphere based on the interhemispheric rivalry model. The intervention consists of 2 weeks, 10 sessions (from Monday to Friday), 45 min each, of tDCS and conventional cognitive stimulation concurrently applied. The tDCS is applied by an 8-channel high definitiontDCS (HD- tDCS) device for 20 min and at 2 mA of intensity. The cathode is positioned over the left posterior parietal cortex (P3 following 10/20 system for electroencephalogram [EEG] electrode placement), and return electrodes are placed at C3, CP5, CP1, Pz, PO3, PO7, and P7. A neuropsychological and functional assessment was carried out at baseline and after the end of the intervention.
The primary aim of the present study is to describe the protocol for a parallel, randomized, triple-blind experimental design. To ensure the feasibility of the protocol and its potential efficacy, a comprehensive description of the procedures applied to a single pilot participant is provided. 
Incorporating tDCS neuromodulation strategies into cognitive rehabilitation processes may lead to shortened intervention times and improve the functional status and quality of life of patients.

The primary aim of the present study is to describe a tDCS intervention protocol for a parallel, randomized, triple-blind clinical trial. To study the feasibility of the intervention, the protocol was applied to a single participant; the results are shown in this paper.
We applied the complete intervention protocol to a 57-year-old male with a high educational level (Journalism Degree) who suffered a stroke in the right basal ganglia nine months before and met all the inclusion criteria for participation in the study.
The pre- and post-intervention results (see Table 4 and Figure 8) are shown for all tasks administered. In the post-intervention assessment quantitative changes were observed in 6 of the 13 measured variables, 4 of which are directly related to neglect.
<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td></td>
			<td colspan="2">Assessments</td>
		</tr>
		<tr>
			<td></td>
			<td>Pre-intervention</td>
			<td>Post-intervention</td>
		</tr>
		<tr>
			<td>MMSE test</td>
			<td>29</td>
			<td>29</td>
		</tr>
		<tr>
			<td>Bells test</td>
			<td>21</td>
			<td>25*</td>
		</tr>
		<tr>
			<td>Cancellation test</td>
			<td>24</td>
			<td>28*</td>
		</tr>
		<tr>
			<td>Drawings test</td>
			<td>12</td>
			<td>12</td>
		</tr>
		<tr>
			<td>Bisection test</td>
			<td>19.95</td>
			<td>3.47*</td>
		</tr>
		<tr>
			<td>BTA test</td>
			<td>11</td>
			<td>9</td>
		</tr>
		<tr>
			<td>Faces Hits</td>
			<td>11</td>
			<td>9</td>
		</tr>
		<tr>
			<td>Faces Errors</td>
			<td>3</td>
			<td>2*</td>
		</tr>
		<tr>
			<td>Direct Digits test</td>
			<td>11</td>
			<td>10</td>
		</tr>
		<tr>
			<td>Inverse Digits test</td>
			<td>9</td>
			<td>8</td>
		</tr>
		<tr>
			<td>Motor Free</td>
			<td>26</td>
			<td>29*</td>
		</tr>
		<tr>
			<td>Barthel test</td>
			<td>25</td>
			<td>30*</td>
		</tr>
		<tr>
			<td>CBS</td>
			<td>20</td>
			<td>20</td>
		</tr>
	</tbody>
</table>
Table 4: Results of pre- and post-intervention assessments. The results of the neuropsychological and functional assessment before and after the intervention are shown in direct scores. *Quantitative improvements in performance in post-intervention assessment compared to baseline. **Values further away from score 0 indicate worse performance and greater neglect.
<img alt="Bar chart comparing pre and post cognitive test scores; includes MMSE, BTA, and Barthel tests results." class="xfigimg" src="/files/ftp_upload/67809/67809fig8.jpg" data-altupdatedat="1788304762000" data-alt="Figure 8"> 
Figure 8: Pre and post intervention assessment results. Higher values ​​indicate positive change, except in the line bisection test, where improvement is represented by lower scores. Results are shown in direct scores. *Quantitative improvements in performance in post-intervention assessment compared to baseline. <a href="https://www.jove.com/files/ftp_upload/67809/67809fig8large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
The percentage improvement between pre- and post-treatment assessment was calculated. Clinical improvement was observed in the specific hemispatial neglect tests: bells test, cancellation test, line bisection, visual motor-free perception test, and Barthel index scale. On the other hand, negative changes were observed in other attentional tasks (digit test, brief test of attention, face test). Finally, no changes appeared in the MMSE, the copy of drawings, or the functional Catherine Bergego Scale (CBS) (See Figure 9).
<img alt="Bar graph showing test score results; analysis of cognitive assessment methods with data comparison." class="xfigimg" src="/files/ftp_upload/67809/67809fig9.jpg" data-altupdatedat="1788304762000" data-alt="Figure 9"> 
Figure 9: Percentage of change between baseline and post-intervention assessment. Results are shown in percentages. Positive scores indicate positive change, except in the line bisection test, where improvement is represented by negative scores. *Percentage of positive improvement when comparing pre- and post-intervention ratings. <a href="https://www.jove.com/files/ftp_upload/67809/67809fig9large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
The study procedures were carried out in spacious rooms equipped for the correct execution of the evaluation and intervention sessions and compliance with safety and hygiene measures.
As for the patient, he did not manifest fatigue in any of the pre- and post-evaluation sessions, so it was not necessary to rest in any of them. The therapy was assessed by the patient as entertaining and stimulating, which improved adherence to treatment and active collaboration throughout the procedure. Therefore, it is considered that the protocol would have high feasibility, and we will continue the study following the established procedure.
In terms of discomfort and side effects, the participant did not experience any moderate or severe side effects related to the application of tDCS.

This study presents a novel transcranial direct current stimulation (tDCS) protocol combined with cognitive stimulation to address post-stroke hemispatial neglect. Initial data from a pilot patient ensure the procedure's feasibility and suggest potential efficacy, providing a foundation for a future parallel, triple-blind, controlled clinical trial.

Right hemisphere stroke frequently results in hemispatial neglect, a disabling condition that can significantly impede the recovery process. The chronic ...

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Learn how high-definition tDCS combined with computerized cognitive stimulation addresses hemispatial neglect in stroke patients. This protocol demonstrates feasibility for enhancing cognitive rehabilitation outcomes.

Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke (Video) | JoVE Journal

Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke

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