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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.


- candidate number24228
- NTR NumberNTR5828
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-apr-2016
- Secondary IDsNL51735.091.15 CCMO
- Public TitleDe 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 TitleThe offline effects of transcranial direct current stimulation (tDCS) on postural balance control after stroke.
- ACRONYMEffects tDCS after stroke
- hypothesisTranscranial 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) studiedStroke, Stroke
- Inclusion criteriaPeople 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 criteriaWith 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.
- Pregnancy.
- 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 16-jan-2016
- planned closingdate31-dec-2016
- Target number of participants45
- Interventionstranscranial 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 outcomeThe main outcome variable is the reaction time in a simple reaction time task and the onset of postural responses.
- Secondary outcomeRelation between the effects of tDCS and structural imaging markers in stroke survivors.
- Timepointsweek 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 siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Milou Coppens
- CONTACT for SCIENTIFIC QUERIES Milou Coppens
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- PublicationsN/A
- Brief summaryTranscranial 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)
- RECORD13-apr-2016 - 22-jun-2016


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