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Noninvasive Brain Stimulation for Stroke (NIBSstroke)

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ClinicalTrials.gov Identifier: NCT01503073
Recruitment Status : Recruiting
First Posted : January 2, 2012
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Pr Yves Vandermeeren, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Stroke Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Noninvasive Brain Stimulation for Stroke Improvement
Actual Study Start Date : January 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2030

Arm Intervention/treatment
Active Comparator: Real stimulation
real NIBS
Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
transcranial direct current stimulation

Sham Comparator: Sham stimulation
sham NIBS
Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
transcranial direct current stimulation




Primary Outcome Measures :
  1. change in function before/after tDCS [ 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 ]
    any brain function impaired by stroke


Secondary Outcome Measures :
  1. change in neuroimaging and neurophysiological before/after tDCS [ 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 ]
    1. noninvasive neuroimaging : brain activity studied by means of fMRI
    2. noninvasive neurophysiological measure : TMS, EEG,evoked potentials, EMG



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503073


Locations
Belgium
Department of Neurology, CHU Mont-Godinne Recruiting
Yvoir, Namur, Belgium, 5530
Contact: Yves Vandermeeren, MD, PhD    +32 81 42 3321    yves.vandermeeren@uclouvain.be   
Sponsors and Collaborators
University Hospital of Mont-Godinne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Yves Vandermeeren, MD, PhD, Professor, MD, PhD, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT01503073     History of Changes
Other Study ID Numbers: B03920073136
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne:
stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases