Post Stroke Motor Learning

Stroke Clinical Trial

Official title:

Post-stroke Procedural Learning: From Neural Substrates to Therapeutic Modulation by Non-invasive Brain Stimulation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01519843
• Other study ID #: B039201212957
• Status: Suspended
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

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)