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The offline effects of brain stimulation(transcranial direct current stimulation, tDCS) on postural balance control after stroke.


- candidate number24004
- NTR NumberNTR5757
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-feb-2016
- Secondary IDsNL51735.091.15 CCMO
- Public TitleThe offline effects of brain stimulation(transcranial direct current stimulation, tDCS) on postural balance control after stroke.
- Scientific TitleThe offline effects of transcranial direct current stimulation (tDCS) on postural balance control after stroke.
- ACRONYMEffects tDCS after stroke
- hypothesisWe hypothesize that anodal tDCS will shorten latencies during both reaction time tasks and balance recovery responses, whereas cathodal tDCS will not influence these latencies. We anticipate on a more variable effect of both stimulation types within the stroke group than within the control group.
- Healt Condition(s) or Problem(s) studiedStroke, Stroke
- Inclusion criteriaOnly people over 18 years old in the chronic phase after experiencing a unilateral stroke (> 6 months in the past) that resulted in hemi pareses will be recruited for this study. Furthermore, healthy controls of similar age and with a similar male:female ratio and 10 healthy young controls (18 - 30 years) will be enrolled in the study for the tDCS sessions only.
- Exclusion criteriaWith regard to transcranial brain stimulation: Serious head trauma or head surgery in the past. 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. Participated in a TMS or tCS study less than 1 year ago. Pregnancy.

With regard to general experimental requirements: Disorders of hearing, which cannot be corrected to normal. Severe vision problems. Skin diseases at intended electrode sites (tDCS or EMG electrodes). Severe cognitive impairment. Any neurological or orthopaedic disorder (other than stroke) that may interfere with task performances. Any prescribed medication that can alter cortical excitability (e.g. anti epileptics, tricyclic anti-depressives or benzodiazepines) within two weeks prior to participation. Medication negatively affecting balance or reaction times (e.g. neuroleptics, antidepressants, anticonvulsants, sedatives).

With regard to MRI: Suffering from claustrophobia. Suffering from epilepsy. Cochlear implant. Irremovable piercing or medical patch.
- 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 over three seperate sessions.
- Primary outcomeMain outcome variable is the reaction time in reaction time tasks and the onset of balance recovery responses.
- Secondary outcomeStructural MRI based markers to explain the anticipated variability on the main outcome variable within people after stroke.
- Timepointsweek 1: Intake measurment 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. A previous study showed that anodal tDCS shortens latencies of simple reaction time tasks and postural recovery responses in young healthy subjects. Here, we hypothesize that anodal tDCS will also shorten latencies of responses in older healthy subjects and in people after stroke, whereas cathodal tDCS will not influence the latencies. We anticipate on a more variable effect of both stimulation types within the stroke group than within the control group.
- Main changes (audit trail)
- RECORD22-feb-2016 - 22-mei-2016


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