Impact of Non-invasive Brain Stimulation on Motor Recuperation
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jan 2012
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 10, 2012
CompletedFirst Posted
Study publicly available on registry
March 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
ExpectedJanuary 10, 2024
January 1, 2024
13.9 years
February 10, 2012
January 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in motor function before/after tDCS
Motor performance improvement with inferior or superior limb
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
Study Arms (2)
Real stimulation
ACTIVE COMPARATORreal tDCS (well, that's the way it is I am not gonna change it)
Sham
SHAM COMPARATORsham tDCS
Interventions
tdcs (ELDITH, Neuroconn, Ilmenau, Germany) transcranial direct current stimulation
Eligibility Criteria
You may qualify if:
- stroke with at least slight deficit in superior or inferior limb
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, CHU Mont-Godinne
Yvoir, Namur,, Belgium
Related Publications (1)
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.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- no change
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 10, 2012
First Posted
March 6, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2025
Study Completion (Estimated)
January 1, 2030
Last Updated
January 10, 2024
Record last verified: 2024-01