tDCS in Post-stroke Neglect Rehabilitation

NCT04458974 | Unknown

• 1 other identifier: tDCS-neglect
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Neglect, Hemispatial

Keywords

neglect; neuropsychological rehabilitation; non-invasive brain stimulation; transcranial direct current stimulation; tDCS; stroke

Outcome Measures

Primary Outcomes (8)

• Change in hemispatial neglect symptomatology

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

  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)

  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)

  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)

  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)

  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)

  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)

  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.

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

Secondary Outcomes (1)

• Side effects and patient comfort assessment

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

Study Arms (3)

Experimental group (Exp)

EXPERIMENTAL

Active tDCS + conventional rehabilitation therapy (physiotherapy and neuropsychological rehabilitation)

Device: Transcranial direct current stimulation; Procedure: Neuropsychological rehabilitation

Sham-tDCS (Sham)

SHAM COMPARATOR

Sham tDCS + conventional rehabilitation therapy (physiotherapy and neuropsychological rehabilitation

Device: Transcranial direct current stimulation; Procedure: Neuropsychological rehabilitation

Control group (Control)

OTHER

Conventional rehabilitation therapy (physiotherapy and neuropsychological rehabilitation) without tDCS.

Procedure: Neuropsychological rehabilitation

Interventions

Transcranial direct current stimulation DEVICE

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.

Experimental group (Exp); Sham-tDCS (Sham)

Neuropsychological rehabilitation PROCEDURE

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).

Control group (Control); Experimental group (Exp); Sham-tDCS (Sham)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Universitat Oberta de Catalunya: lead
• Hospital Beata María Ana: collaborator
• Universidad Francisco de Vitoria: collaborator

Study Sites (1)

Hospital Beata María Ana (Brain Damage Unit)

Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Stroke; Perceptual Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Elena M Marron, PhD

CONTACT

+34620912976; emunozmarr@uoc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel, randomized, controlled and triple blind experimental study

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: July 7, 2020
• Study Start: November 8, 2019
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)