Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation

NCT ID: NCT02512289

Last Updated: 2018-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-09

Study Completion Date

2015-07-30

Brief Summary

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tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.

Detailed Description

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tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb.

tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after tDCS, associated with RAT.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Real stimulation

real tDCS associated with robot-assisted therapy (RAT)

Group Type ACTIVE_COMPARATOR

tDCS (ELDITH) and RAT (REAplan)

Intervention Type DEVICE

Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan

Sham stimulation

Sham tDCS associated with RAT

Group Type SHAM_COMPARATOR

tDCS (ELDITH) and RAT (REAplan)

Intervention Type DEVICE

Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan

Interventions

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tDCS (ELDITH) and RAT (REAplan)

Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* stroke with at least slight deficit in upper limb

Exclusion Criteria

* epilepsy
* contraindication to tDCS
* presence of metal in the head
* inability to understand/complete behavioural tasks
* chronic intake of alcohol or recreative drugs
* major health condition (e.g. terminal renal failure, instable heart failure etc …)
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Mont-Godinne

OTHER

Sponsor Role collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Lejeune, Professor

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires Saint Luc

Brussels, , Belgium

Site Status

CHU Dinant-Godinne UCL

Mont Godinne, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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IONS-Gilliaux-03

Identifier Type: -

Identifier Source: org_study_id

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