|- candidate number||11252|
|- NTR Number||NTR3315|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-feb-2012|
|- Secondary IDs||NL39593.044.12 CCMO|
|- Public Title||The effect of non invasive brain stimulation on learning leg movements.|
|- Scientific Title||The effect of non invasive brain stimulation on lower limb motor skill acquisition.|
|- hypothesis||Motor cortex or cerebellar tDCS(transcranial Direct Current Stimulation) will enhance motor skill learning in heatlhy subjects and chronic stroke survivors. Stimulating the motor cortex will result in an increase in offline learning, whereas stimulating the cerebellum will result in an increase in online learning.|
|- Healt Condition(s) or Problem(s) studied||Stroke, tDCS, Motor skill learning|
|- Inclusion criteria||For healthy subjects:|
1. Age > 18 years;
2. Able to stand and make stepping movements for in total 42 minutes;
3. Good vision (on 2 m distance).
Additional for stroke patients:
1. Diagnosed with a hemiparesis as the result of a first ever, ischemic subcortical stroke;
2. Chronic stage: time since stroke > 6 months;
3. Independent walkers with clear walking impairment.
|- Exclusion criteria||1. Metallic implants in the brain;|
2. Presensce of severe or frequent headache;
3. Other neurological disorders or orthopedic problems;
4. Have a history of cardiac conditions that interfere with physical load.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2012|
|- planned closingdate||1-sep-2013|
|- Target number of participants||60|
|- Interventions||Subjects will participate in three training sessions and receive tDCS (transcranial Direct Current Stimulation) during the first 10 minutes of every training session. Every experimental group receives one type of stimulation, being anodal motor cortex stimulation, anodal cerebellar stimulation or sham (placebo) stimulation.|
|- Primary outcome||Relative change in motor skill between the first and last training block (total learning).
From the first and last training block of every training session the mean movement time and the error rate is calculated. By combining these two parameters with the SAF the motor skill of these two blocks are calculated. The motor skills from all training sessions together are used to calculate the main parameter total learning and the secondary parameters on- and offline learning.
|- Secondary outcome||1. Change in motor skill during motor skill training (online learning);|
2. Change in motor skill between two consecutive motor skill trainings (offline learning).
|- Timepoints||Total learning: after day 3
Online learning: After day 1,2,3
Offline learning: After day 2,3|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Edwin Asseldonk, van|
|- CONTACT for SCIENTIFIC QUERIES|| Edwin Asseldonk, van|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The primary objective of this study is to assess whether anodal motor cortex- or anodal cerebellar tDCS can enhance motor skill learning in the lower extremities in chronic stroke survivors and healthy subjects.
This study is a double blind randomized controlled trial. All subjects participate in three experimental training sessions on consecutive days and receive tDCS during the first 10 minutes of every training session. Every experimental group receives one type of stimulation, being anodal motor cortex stimulation, anodal cerebellar stimulation or sham (placebo) stimulation.
It is of importance to conduct this study to know whether tDCS results in any beneficial lasting effects on motor learning. If so, the role of different brain areas in motor skill learning will be better understood and in future studies we can try to maximize these beneficial effects on rehabilitation of walking.|
|- Main changes (audit trail)|
|- RECORD||29-feb-2012 - 29-mrt-2012|