|- candidate number||24228|
|- NTR Number||NTR5828|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-apr-2016|
|- Secondary IDs||NL51735.091.15 CCMO|
|- Public Title||De offline effecten van hersenstimulatie (type tDCS) op balanshandhaving na een beroerte. / The offline effects of brain stimulation (type tDCS) on balance control after stroke. |
|- Scientific Title||The offline effects of transcranial direct current stimulation (tDCS) on postural balance control after stroke. |
|- ACRONYM||Effects tDCS after stroke|
|- hypothesis||Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that increases (anodal tDCS) or decreases (cathodal tDCS) cortical excitability. We hypothesize that anodal tDCS shortens latencies of responses during both simple reaction time tasks and balance recovery responses. We do not expect that cathodal tDCS will shorten these motor responses. Furthermore, we hypothesize that the effects of tDCS will be more variable in people after stroke compared to healthy controls.|
|- Healt Condition(s) or Problem(s) studied||Stroke, Stroke|
|- Inclusion criteria||People over 18 years old in the chronic phase after experiencing a supratentorial unilateral stroke (> 6 months ago) that resulted in a hemiparesis. Furthermore, healthy controls of similar age and young healthy controls (18-30 years) will be included.|
|- Exclusion criteria||With regard to the tDCS measurements:|
- Neurological or orthopedic conditions affecting balance.
- Medication negatively affecting balance or reaction times.
- Disorders of hearing, which cannot be corrected to normal.
- Severe vision problems.
- Severe cognitive impairments.
- Serious head trauma or brain surgery.
- Large or ferromagnetic metal parts in the upper body (except for dental fillings and wire).
- Implanted cardiac pacemaker or neurostimulator (too close to the head) or Venous Access Port.
- Skin diseases at intended electrode sites (tDCS or EMG electrodes).
- Any prescribed medication that can alter cortical excitability.
- Participated in a TMS or tCS study less than 1 year ago.
Additional criteria with regard to MRI measurement:
- Suffering from claustrophobia
- Suffering from epilepsy
- Cochlear implant
- Irremovable piercing or medical patch
- Any head, neck or shoulder surgeries in the past.
- BMI > 35
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||16-jan-2016|
|- planned closingdate||31-dec-2016|
|- Target number of participants||45|
|- Interventions||transcranial direct current stimulation (tDCS); 2mA for 15 minutes. Anodal, cathodal and sham stimulation will be applied on M1 in a random order across participants.|
|- Primary outcome||The main outcome variable is the reaction time in a simple reaction time task and the onset of postural responses.|
|- Secondary outcome||Relation between the effects of tDCS and structural imaging markers in stroke survivors.|
|- Timepoints||week 1: Intake measurement (stroke participants)|
week 2: MRI scan (stroke participants)
week 3: tDCS measurement 1 (stroke and control participants)
week 4: tDCS measurement 2 (stroke and control participants)
week 5: tDCS measurement 3 (stroke and control participants)
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Milou Coppens|
|- CONTACT for SCIENTIFIC QUERIES|| Milou Coppens|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Brief summary||Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that alters cortical excitability. In a previous study was shown that anodal tDCS facilitates balance recovery responses in young healthy people. Here, we investigate whether facilitation of balance responses also occurs in people after stroke. Furthermore, we investigate the effect of cathodal tDCS on the same balance responses and the relation between tDCS effects and structural imaging markers. |
|- Main changes (audit trail)|
|- RECORD||13-apr-2016 - 22-jun-2016|