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Brain stimulation for arm recovery after stroke


- candidate number25611
- NTR NumberNTR6133
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-nov-2016
- Secondary IDsNL58423.041.16 
- Public TitleBrain stimulation for arm recovery after stroke
- Scientific TitleBrain stimulation for arm recovery after stroke
- ACRONYMB-STARS
- hypothesisBetter and faster recovery of arm/hand for patients treated with rTMS
- Healt Condition(s) or Problem(s) studiedParese, Stroke, Upper extremity, Hands
- Inclusion criteria1) Adult patient > 18 years
2) First-ever unilateral stroke
3) paresis of one arm, with a SAFE score shoulder abduction >9 (Motricity Index), Finger extension > 1 (Fugl-Meyer)
4) within the first 1-2 weeks after stroke
5) signed informed consent
- Exclusion criteria1) disabling medical history (severe of recent heart disease, severe head trauma, coercively treated at at psychiatric ward)
2) history of epilepsy
3) normal to almost normal use of hand; maximum Motricity Index score of 33
4) severe deficits in communication, memory or understanding that impede proper study participation, as indicated by the treating physician
5) contraindications for TMS and MRI
5a) metal (implants) in skull/scalp/head or fragments from welding or metalwork
5b) implanted device (e.g. spinal cord stimulator, cardiac pacemaker, cochlear implants)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-jan-2017
- planned closingdate1-jan-2021
- Target number of participants60
- InterventionsrTMS
- Primary outcomeMotor outcome: Action Research Arm Test (ARAT)
- Secondary outcomeAdditional motor outcomes
Brain reorganization
Lifestyle outcomes
- TimepointsBefore stimulation
10th day of stimulation
1 week after stimulation
1 month after stimulation
3 months after stimulation
6 months after stimulation
1 year after stimulation
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIES Eline van Lieshout
- CONTACT for SCIENTIFIC QUERIES Eline van Lieshout
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD28-nov-2016 - 3-jan-2017


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