Noninvasive Brain Stimulation for Stroke (NIBSstroke)
Primary Purpose
Stroke
Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke
Eligibility Criteria
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
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 stimulation
Arm Description
real NIBS
sham NIBS
Outcomes
Primary Outcome Measures
change in function before/after tDCS
any brain function impaired by stroke
Secondary Outcome Measures
change in neuroimaging and neurophysiological before/after tDCS
noninvasive neuroimaging : brain activity studied by means of fMRI
noninvasive neurophysiological measure : TMS, EEG,evoked potentials, EMG
Full Information
NCT ID
NCT01503073
First Posted
December 23, 2011
Last Updated
May 8, 2023
Sponsor
University Hospital of Mont-Godinne
1. Study Identification
Unique Protocol Identification Number
NCT01503073
Brief Title
Noninvasive Brain Stimulation for Stroke
Acronym
NIBSstroke
Official Title
Noninvasive Brain Stimulation for Stroke Improvement
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Study Start Date
January 2008 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 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
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.
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real stimulation
Arm Type
Active Comparator
Arm Description
real NIBS
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
sham NIBS
Intervention Type
Device
Intervention Name(s)
tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
Intervention Description
transcranial direct current stimulation
Primary Outcome Measure Information:
Title
change in function before/after tDCS
Description
any brain function impaired by stroke
Time Frame
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
Secondary Outcome Measure Information:
Title
change in neuroimaging and neurophysiological before/after tDCS
Description
noninvasive neuroimaging : brain activity studied by means of fMRI
noninvasive neurophysiological measure : TMS, EEG,evoked potentials, EMG
Time Frame
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
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
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
Facility Information:
Facility Name
Department of Neurology, CHU Mont-Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
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
PubMed Identifier
23486918
Citation
Lefebvre S, Thonnard JL, Laloux P, Peeters A, Jamart J, Vandermeeren Y. Single session of dual-tDCS transiently improves precision grip and dexterity of the paretic hand after stroke. Neurorehabil Neural Repair. 2014 Feb;28(2):100-10. doi: 10.1177/1545968313478485. Epub 2013 Mar 13.
Results Reference
derived
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Noninvasive Brain Stimulation for Stroke
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