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POTENTIALcross


- candidate number21296
- NTR NumberNTR4947
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2015
- Secondary IDsNL48397.029.14 
- Public TitlePOTENTIALcross
- Scientific Title‘POTENTIALcross: ‘Effects of Non-invasive Transcranial direct current stimulation on posturographical and neurophysiological parameters in healthy and stroke.’
- ACRONYMPOTENTIALcross
- hypothesis
- Healt Condition(s) or Problem(s) studiedIschemic stroke, Balance, tDCS
- Inclusion criteria1) a lower extremity deficit as determined by a score of < 12 points on the short physical performance battery (SPPB), 2) a first ever ischemic lesion in the territory of the MCA as verified by CT of MRI scan, 3) age >18, 4) written informed consent, 5) be able to stand for 30 seconds without support 6) normal vision or corrected to normal with an optical aid,7) able and sufficiently motivated to perform the required tests and interventions. Healthy subjects participating in this study have to meet criteria 3, 4, 5, 6 and 7.
- Exclusion criteriaThe exclusion criteria are as follows: 1) Any metallic implants (pacemaker etc.) , 2) orthopedic limitations that interfere with the study, 3) not being able to communicate, 3) successful thrombolysis treatment, 4) Cranial bone defects, 5) history of epileptic seizures, 6) diagnoses bipolar or psychiatric disorder 7) signs of depression (Hospital Anxiety and Depression Scale, HADS, sub score D >7) (Zigmond and Snaith, 1983), 8) insufficient cognitive function (Mini Mental State Examination, MMSE < 19), 9) sensory impairments (prior to the ischemic lesion, in case of patients), 10) diagnosed diseases of the vestibular system,11) therapy focusing on balance improvement during the time period in which the measurements take place. Potential healthy subjects for this study will be excluded in case of: 1) History of any disease, condition, event or use of medication that interferes with the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2015
- planned closingdate24-aug-2016
- Target number of participants20
- InterventionsStroke patients and healthy age matched subjects will recive tDCS or sham tDCS on the cerebellum during a balance tracking task
- Primary outcomeBalance control parameters
- Secondary outcomeneurophysiological parameters
- Timepointsdirectly after stimulation
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Sarah Zandvliet
- CONTACT for SCIENTIFIC QUERIES Erwin van Wegen
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Hersenstichting Nederland
- Publications
- Brief summaryPostural instability, balance problems and subsequent falls are very common in patients with a stroke.Studies suggest that a positive, reproducible effect on motor learning may be achieved by simultaneous non-invasive transcranial direct current stimulation (tDCS) and motor training.Knowledge regarding the instantaneous effects of tDCS during single session PFT tasks is lacking in literature at the moment. In addition, non-invasive cerebellar brain stimulation has to date not been applied in stroke subjects. In this study, the effect of cerebellar tDCS during a balance tracking task will be studied in chronic stroke patients and healthy age matched subjects. Both posturographical and neurophysiological data will be collected.
- Main changes (audit trail)
- RECORD6-jan-2015 - 27-aug-2017


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