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NCT02512289 Clinical Trial

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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02512289
Other study ID # IONS-Gilliaux-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 9, 2014
Est. completion date July 30, 2015

Study information
Verified date August 2018
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date July 30, 2015
Est. primary completion date January 9, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• tDCS (ELDITH) and RAT (REAplan)
Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan

Locations
Country Name City State
Belgium Cliniques Universitaires Saint Luc Brussel
Belgium CHU Dinant-Godinne UCL Mont Godinne

Sponsors (2)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain University Hospital of Mont-Godinne

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Upper Limb Kinematics kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Secondary Box and Block test Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Secondary Purdue Pegboard Test Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
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