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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01519843
Other study ID # B039201212957
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date December 2030

Study information

Verified date May 2023
Source University Hospital of Mont-Godinne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning. Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.


Description:

transcranial direct current stimulation will be used for NIBS


Recruitment information / eligibility

Status Suspended
Enrollment 100
Est. completion date December 2030
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: - stroke with at least slight deficit Exclusion Criteria: - epilepsy - contraindication to tDCS and/or to fMRI - presence of metal in the head - inability to understand / complete behavioral tasks - chronic intake of alcohol or recreational drugs - major health condition - presence of pacemaker (for the fMRI part only) - pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
transcranial direct current stimulation tDCS
tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
transcranial magnetic stimulation TMS
TMS (The Magstim Company Ltd, UK) Magstim 200² with a figure-of-eight coil was used to determine the hot spot eliciting consistent movements in the contralateral hand

Locations

Country Name City State
Belgium Department of Neurology, CHU Mont-Godinne Yvoir Namur

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Mont-Godinne

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motor learning improvement with tDCS performance on a motor skill learning task and on different commonly used task (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT ,...) were measured to explore the impact of tDCS on these parameters Improvement on motor learning were recorded from baseline to 4 weeks after the intervention
Secondary Neuroimaging Does cerebral mechanisms underlying motor learning differ from healthy subject to stroke patients? before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS)
Secondary Neurophysiological outcome measure measure of brain excitability and connectivity with TMS (single and paired pulse) start of session 5min before motor learning, just at the end of the motor learning, after 30 min of motor learning, after 60 min of motor learning, Recall test at 1,2,3,4 weeks after the day of intervention (with or without tDCS)
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