Noninvasive Brain Stimulation for Stroke

Not Applicable

Suspended

• Conditions: Stroke
• Interventions: Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)

• Registration Number: NCT01503073
• Lead Sponsor: University Hospital of Mont-Godinne

Brief Summary

Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.

Detailed Description

Noninvasive brain stimulations (NIBS) will be used in acute and chronic stroke patients to improve a variety of functions such as motor functions, cognitive functions, ...

NIBS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after NIBS, as well as brain functional imaging data.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2011-12-23
• Study First Submitted QC: 2011-12-30
• Study First Posted: 2012-01-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Primary Completion: 2025-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• stroke with at least slight deficit

Exclusion Criteria

• epilepsy
• contraindication to tDCS and/or to fMRI
• presence of metal in the head
• unability to understand / complete behavioural tasks
• chronic intake of alcohol or recreative drugs
• major health condition
• presence of pacemaker
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Real stimulation	tdcs (ELDITH, Neuroconn, Ilmenau, Germany)	real NIBS
Sham stimulation	tdcs (ELDITH, Neuroconn, Ilmenau, Germany)	sham NIBS

Primary Outcome Measures

Name	Time	Method
change in function before/after tDCS	Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months	any brain function impaired by stroke

Secondary Outcome Measures

Name	Time	Method
change in neuroimaging and neurophysiological before/after tDCS	Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months	1. noninvasive neuroimaging : brain activity studied by means of fMRI; 2. noninvasive neurophysiological measure : TMS, EEG,evoked potentials, EMG

Trial Locations

Locations (1)

Department of Neurology, CHU Mont-Godinne; 🇧🇪 Yvoir, Namur, Belgium