An interventional study of Transcranial direct current stimulation and Neuropsychological rehabilitation in Stroke and Neglect, Hemispatial, sponsored by Universitat Oberta de Catalunya. Completed at 1 site in Spain. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Universitat Oberta de Catalunya · Not applicable, Interventional, and Treatment
Introduction
Stroke is the main cause of disability in the world and its sequelae have a great impact in the functional independence and quality of life of patients and families. Unilateral spatial neglect is one of the most frequent cognitive deficits after stroke, and its maintenance is associated with poor functional outcome of the rehabilitation process.
For many years clinical research has been conducted to develop new and effective rehabilitation strategies for neglect. Noninvasive brain stimulation (NIBS) techniques are important tools in this regard, and it should be considered as a therapeutic intervention used in combination with conventional neuropsychological approaches. Transcranial direct current stimulation (tDCS) is a noninvasive, safe, neurophysiological technique able to modulate cortical activity by inducing a weak electric current into the brain.
The studies focused on neglect symptoms treatment by means of tDCS over the lesional and contralesional hemisphere have shown promising results and its combination with conventional neglect therapies may enhance treatment efficacy and speed the recovery.
Objectives
To improve neglect symptoms by reducing the pathological hyperactivity of the undamaged hemisphere after right medial cerebral artery stroke, through the application of multisite tDCS, and to validate a NIBS protocol for the enhancement of conventional neuropsychological rehabilitation outcome.
Methods
The sample will be composed by 30 patients with spatial neglect secondary to a ischemic stroke in the middle cerebral artery in subacute stage (3 to 12 months since the event). The patients will be randomly assigned to one experimental group (Active, Sham, and Control).
The intervention protocol consists in a two weeks intervention (10 sessions, 45 min, Monday to Friday) of tDCS and neuropsychological rehabilitation applied concurrently. In each session a 20 min tDCS at 2 milliamps (m will be applied over P3 according to 10/20 EEG international system (cathodal) with return electrodes placed in C3,CP5,CP1,Pz,PO3,PO7,P7 (10/20 EEG). StarStim® tDCS 8 channels Multisite device will be used.
Transcranial direct current stimulation (tDCS) is a safe and non-invasive neurophysiological technique with enough scientific literature that supports its effectiveness and safety, both in healthy subjects and in different neurological pathologies.
However, it has not been consolidated yet as a real clinical alternative for other pathologies different from depression, due to the impossibility of establishing specific intervention protocols given the heterogeneity of the samples and the methods of assessment of the results used in the different studies.
Regarding stroke, although there is large empirical evidence of its effectiveness in motor rehabilitation, there are few studies to date focused on cognitive rehabilitation, such neglect rehabilitation.
Hypothesis
The main hypothesis is that patients who receive a treatment based on tDCS in combination with conventional neuropsychological intervention for the recovery of neglect will have a greater improvement in neglect symptomatology in comparison to patients who receive the conventional treatment in isolation.
Objectives
The main objective of the project is to validate a protocol for the enhancement of conventional neuropsychological rehabilitation using tDCS in a group of patients with spatial neglect secondary to a cortical ischemic stroke in the middle cerebral artery (MCA) in a subacute phase (3 to 12 months since the event).
Specific objectives:
Methods
Design:
The present study is a parallel, randomized, controlled and triple blind experimental study. The patients included in the sample will be randomly distributed into three groups (Exp, Sham and Control) that will be blind to the patients, to the researchers who apply the tDCS and to the pre and post intervention evaluators.
The duration of the study will be 3 years.
Sample:
The sample will consist of 30 volunteer patients randomly distributed to one of the experimental condition (1:1:1) with blind of the randomization sequence. Randomization will be done with the help of the research support department of the Francisco de Vitoria University. Patients will be recruited in the Brain Damage Unit of Beata María Ana Hospital by the unit neurologist and neuropsychologists among those patients who meet the inclusion criteria.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Universitat Oberta de Catalunya is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active tDCS + conventional rehabilitation therapy (physiotherapy and neuropsychological rehabilitation)
Device: Transcranial direct current stimulation · Procedure: Neuropsychological rehabilitation
Sham tDCS + conventional rehabilitation therapy (physiotherapy and neuropsychological rehabilitation
Device: Transcranial direct current stimulation · Procedure: Neuropsychological rehabilitation
Conventional rehabilitation therapy (physiotherapy and neuropsychological rehabilitation) without tDCS.
Procedure: Neuropsychological rehabilitation
The intervention consists in two-weeks treatment, 10 consecutive sessions of tDCS ( Monday to Friday) applied concurrently to neuropsychological rehabilitation. The tDCS Multisite StratStim® 8-channel device (Neuroelectrics) will be used for tDCS stimulation. The duration of the stimulation will be 20 minutes at 2 mA. The tDCS will be applied with the cathode positioned in P3 (following the international 10/20 EEG system), and the return electrodes will be placed in C3, CP5, CP1, Pz, PO3, PO7, P7. The sessions will last 1 hour.
The neuropsychological rehabilitation protocol has been designed for the recovery of neglect symptomatology. Each session will consist on the performance of different cognitive stimulation tasks aimed at improving attention and visoperceptive abilities. The tasks will be applied through the NeuronUp neurorehabilitation platform in order to achieve maximum homogeneity and objectivity across patients. The neuropsychological rehabilitation will last 30min (in 1h intervention session).
Change in hemispatial neglect symptomatology
Change in hemispatial neglecteglect sympthomatology assessed by The Bell Test (Gauthier, Dehaut, and Joanette 1989)
Time frame: Pre and post intervention (3 days after the end of intervention)
Change in hemispatial neglect symptomatology
Change in hemispatial neglecteglect sympthomatology assessed by Copy of drawings subtest Barcelona test (Peña Casanova 2005)
Time frame: Pre and post intervention (3 days after the end of intervention)
Change in hemispatial neglect symptomatology
Change in hemispatial neglecteglect sympthomatology assessed by Line bisection test (Schenkenberg, Bradford, and Ajax 1980)
Time frame: Pre and post intervention (3 days after the end of intervention)
Change in hemispatial neglect symptomatology
Change in hemispatial neglecteglect sympthomatology assessed by The motor-free visual perception test (MVPT): (Colarusso, Hammill, and Academic Therapy Publications 1995)
Time frame: Pre and post intervention (3 days after the end of intervention)
Change in functional independence
Change in functional independence assessed by The Catherine Bergego Scale (Azouvi et al. 2003)
Time frame: Pre and post intervention (3 days after the end of intervention)
Change in functional independence
Change in functional independence assessed by Barthel Index (Mahoney and Barthel 1965)
Time frame: Pre and post intervention (3 days after the end of intervention)
Change in general cognitive functioning
Change in general cognitive functioning assessed by Mini-mental state examination (MMSE) (Folstein, Folstein, and McHugh 1975)
Time frame: Pre and post intervention (3 days after the end of intervention)
Change in neurophysiological assessment
Change in neurophysiological assessment through a resting state EEG acquisition. EEG will be recorded at rest using 64 electrodes in a system 10-20 distribution. An actiCHamp amplifier (Brain Vision LLC, North Carolina, United States) will be used to amplify and digitize the EEG data at a sampling frequency of 512 Hz. Alpha, Beta, Theta and Gamma bands will be recorded.
Time frame: Pre and post intervention (3 days after the end of intervention)
Side effects and patient comfort assessment
Assessment of the presence or not of side effects and comport or discomfort of the patient during the intervention
Time frame: Pre and post session (before and at the end of every session - 1 min after the end of the session)
Plan to share: No
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Universitat Oberta de Catalunya