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StroketDCS-NeglectNCT04458974

tDCS in Post-stroke Neglect Rehabilitation

A study testing Transcranial direct current stimulation and Neuropsychological rehabilitation in people with Stroke and Neglect, Hemispatial, run by Universitat Oberta de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Stroke, Neglect, Hemispatial
What is being tested?
Transcranial direct current stimulation and Neuropsychological rehabilitation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteSpain
Study dates
8 Nov 2019to 25 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hemorrhagic or ischemic stroke in the right hemisphere.
  • Stroke 3 to 12 months since the event (regardless of whether or not they have received prior rehabilitation).
  • 18 to 99 years-old.
  • Neuroimaging study.
  • Absence of previous strokes.
  • Functional capacity that allows him/her to remain seated and active for one hour (Barthel Index score greater than 5 in the item of transfers between chair and bed; this item can be scored from 0 to 15, being 0 totally dependent and 15 totally independent).
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  • Right-handed manual dominance
  • Neglect scores on at least two of the three tests administered for the assessment of visuospatial neglect.
  • Signature of informed consent by the patient or his/her legal guardian.

Who cannot join

  • Dermatological problems (psoriasis, dermatitis on the scalp or face).
  • Presence of implants or metal parts in the head excluding fillings.
  • Pacemakers, medication pumps, stimulators (vagal, cerebral, transcutaneous), ventriculoperitoneal shunts or aneurysm clips.
  • Presence of previous strokes.
  • Neurological disease other than stroke described in the inclusion criteria.
  • Severe cognitive impairment assessed using the Mini-mental state examination (MMSE), excluding patients with scores under 24 (the score of MMSE are between 0 and 30, being 0 severe cognitive impairment and 30 no cognitive impairment).
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  • Significant language difficulties that not allow proper understanding of activities or severely limit expression.
  • History of alcohol or drug abuse.
  • Moderate or severe active depression.
  • Uncontrolled medical problems (pathologies in acute phase without medical or pharmacological treatment with proven efficacy or pathologies with imminent life risk).
  • Pregnancy or suspected pregnancy that will be checked by pregnancy test at the beginning of the study in patients of childbearing age and with the recommendation of the use of contraceptive methods until the end of the intervention.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Beata María Ana (Brain Damage Unit)

    Madrid, Madrid, 28007

Other trials in Spain

About this study

Official title: Transcranial Direct Current Stimulation as Coadjuvant Intervention in Post-stroke Neglect Rehabilitation

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.

Read more

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.

Read the detailed description

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:

  • To demonstrate that non-invasive neuromodulation by means of tDCS enhances the efficacy of the conventional neuropsychological rehabilitation.
  • Identify clinical and neurophysiological variables of the patients are the best predictors of the efficacy of the combined treatment.
  • To verify the greater impact of the combined treatment in the improvement of the symptomatology of neglect as well as in the patient's quality of life in comparison with the conventional intervention.

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.

  • Experimental group (Exp): active tDCS + conventional neuropsychological rehabilitation.
  • Control group placebo-tDCS (Sham): placebo tDCS (sham) + conventional neuropsychological rehabilitation.
  • Control group (Control): conventional neuropsychological rehabilitation without tDCS.

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.

Being tested
Transcranial direct current stimulation, Neuropsychological rehabilitation
Keywords
neglect, neuropsychological rehabilitation, non-invasive brain stimulation, transcranial direct current stimulation, tDCS, stroke
Medical subject headings
Stroke, Perceptual Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial direct current stimulationDevice

    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.

  • Neuropsychological rehabilitationProcedure or surgery

    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).

Study groups in NCT04458974
Study groupRoleWhat they receive
Experimental group (Exp)ExperimentalActive tDCS + conventional rehabilitation therapy (physiotherapy and neuropsychological rehabilitation)
Receives: Device: Transcranial direct current stimulation; Procedure: Neuropsychological rehabilitation
Sham-tDCS (Sham)Sham comparatorSham tDCS + conventional rehabilitation therapy (physiotherapy and neuropsychological rehabilitation
Receives: Device: Transcranial direct current stimulation; Procedure: Neuropsychological rehabilitation
Control group (Control)OtherConventional rehabilitation therapy (physiotherapy and neuropsychological rehabilitation) without tDCS.
Receives: Procedure: Neuropsychological rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in hemispatial neglect symptomatology

    Change in hemispatial neglecteglect sympthomatology assessed by The Bell Test (Gauthier, Dehaut, and Joanette 1989)

    Measured: Pre and post intervention (3 days after the end of intervention)

  2. Change in hemispatial neglect symptomatology

    Change in hemispatial neglecteglect sympthomatology assessed by Copy of drawings subtest Barcelona test (Peña Casanova 2005)

    Measured: Pre and post intervention (3 days after the end of intervention)

  3. Change in hemispatial neglect symptomatology

    Change in hemispatial neglecteglect sympthomatology assessed by Line bisection test (Schenkenberg, Bradford, and Ajax 1980)

    Measured: Pre and post intervention (3 days after the end of intervention)

  4. 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)

    Measured: Pre and post intervention (3 days after the end of intervention)

  5. Change in functional independence

    Change in functional independence assessed by The Catherine Bergego Scale (Azouvi et al. 2003)

    Measured: Pre and post intervention (3 days after the end of intervention)

  6. Change in functional independence

    Change in functional independence assessed by Barthel Index (Mahoney and Barthel 1965)

    Measured: Pre and post intervention (3 days after the end of intervention)

  7. Change in general cognitive functioning

    Change in general cognitive functioning assessed by Mini-mental state examination (MMSE) (Folstein, Folstein, and McHugh 1975)

    Measured: Pre and post intervention (3 days after the end of intervention)

  8. 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.

    Measured: Pre and post intervention (3 days after the end of intervention)

Secondary outcomes (1)
  1. 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

    Measured: Pre and post session (before and at the end of every session - 1 min after the end of the session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start8 Nov 2019
  3. Primary completion3 Nov 2025
  4. Study completion25 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel, randomized, controlled and triple blind experimental study
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04458974
Sponsor's protocol ID
tDCS-neglect
Acronym
tDCS-Neglect
Status last verified
Jul 2026
First submitted
12 Nov 2019
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gonzalez Rodriguez B, Marron EM, Rios-Lago M, Arroyo Ferrer A, Gonzalez-Zamorano Y, Sanchez Cuesta FJ, De Norena D, Romero JP. Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke. J Vis Exp. 2025 Jun 6;(220). doi: 10.3791/67809.

    PubMed 40549788

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation and Neuropsychological rehabilitation in people with Stroke and Neglect, Hemispatial, run by Universitat Oberta de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hemispatial neglect symptomatology (time frame: Pre and post intervention (3 days after the end of intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04458974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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tDCS in Post-stroke Neglect Rehabilitation | AzTrials