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Impact of Non-invasive Brain Stimulation on Motor Recuperation

Primary Purpose

Stroke

Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
tDCS (ELDITH)
Sponsored by
University Hospital of Mont-Godinne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • stroke with at least slight deficit in superior or inferior limb

Exclusion Criteria:

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

Sites / Locations

  • Department of Neurology, CHU Mont-Godinne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real stimulation

Sham

Arm Description

real tDCS (well, that's the way it is I am not gonna change it)

sham tDCS

Outcomes

Primary Outcome Measures

change in motor function before/after tDCS
Motor performance improvement with inferior or superior limb

Secondary Outcome Measures

Full Information

First Posted
February 10, 2012
Last Updated
May 8, 2023
Sponsor
University Hospital of Mont-Godinne
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1. Study Identification

Unique Protocol Identification Number
NCT01544699
Brief Title
Impact of Non-invasive Brain Stimulation on Motor Recuperation
Official Title
Impact of Non-invasive Brain Stimulation on Motor Recuperation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Mont-Godinne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to improve a variety of functions with superior or inferior limb.
Detailed Description
tDCS will be used in chronic stroke patients to improve a variety of functions such as motor functions with superior or inferior limb. tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after tDCS, as well as brain functional imaging data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
no change
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
no change
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real stimulation
Arm Type
Active Comparator
Arm Description
real tDCS (well, that's the way it is I am not gonna change it)
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
sham tDCS
Intervention Type
Device
Intervention Name(s)
tDCS (ELDITH)
Intervention Description
tdcs (ELDITH, Neuroconn, Ilmenau, Germany) transcranial direct current stimulation
Primary Outcome Measure Information:
Title
change in motor function before/after tDCS
Description
Motor performance improvement with inferior or superior limb
Time Frame
Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: stroke with at least slight deficit in superior or inferior limb Exclusion Criteria: epilepsy contraindication to tDCS and/or to fMRI presence of metal in the head inability to understand/complete behavioural tasks chronic intake of alcohol or recreative drugs major health condition presence of pacemaker pregnancy
Facility Information:
Facility Name
Department of Neurology, CHU Mont-Godinne
City
Yvoir,
State/Province
Namur,
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived

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Impact of Non-invasive Brain Stimulation on Motor Recuperation

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