Patient-tailored Transcranial Direct Current Stimulation to Improve Stroke Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChristina Kruuse
About this trial
In a double-blinded sham-controlled study the effect of patient-tailored transcranial direct current stimulation during rehabilitation training will be examined.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
Ischemic stroke confirmed by clinical and imaging criteria
Hemiparesis including reduced upper-extremity function
Location of stroke either cortically involving middle cerebral artery or the anterior cerebral artery circulation or subcortical (involving thalamus, basal ganglia).
Disqualifiers
>50% stenosis of extra- or intracranial artery as well as vascular malformations or aneurisms detected by brain CT-angiography.
Exclusively ischemic stroke in spine, pons, brainstem, medulla or cerebellum.
History of seizures, epilepsy, anxiety, dementia alcohol- or drug abuse.
Prior serious head injury or neurosurgery
Trial design
Design model
Parallel
Treatments tested in this trial
Active Transcranial Direct Current Stimulation
DeviceSee arm/group description
Sham stimulation
DeviceSee arm/group description
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Active Transcranial Direct Current StimulationActive comparator 1 intervention
Group B: Sham stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pilot outcome
Difference in Upper-extremity Fugl-Meyer Assessment (UE-FMA) score at end of treatment. Range 0-66.
Time frame
From baseline to four monthsSecondary outcomes
1
Change in upper-extremity function
Difference in change in Action Reach Arm Test (ARAT) score. Range 0-57. High scores mean a better outcome.
Time frame
From baseline to four months2
Stroke severity
Difference in change in National Health Institutes Stroke Scale (NIHSS). Range 0-42. High scores mean a better outcome.
Time frame
From baseline to four months3
Stroke disability
Difference in change in Modified Rankin Scale (mRS). Range 0-6. Lower scores mean a better outcome.
Time frame
From baseline to four months4
ADL performance
Difference in change in Bartel's 20-item Index (BI-20). Range 0-100. Higher scores mean better outcome.
Time frame
From baseline to four monthsOther outcomes
1
Brain Derived Neutrotrophic Factor (BDNF) genetic polymorphism
Determination of BDNF genetic variant - either Val66Met variant or wildtype.
Time frame
Baseline2
Feasibility of intervention
Completion of intervention in the active vs. control group
Time frame
From baseline to four months3
TMS - motor evoked potential
Determination of existence of a MEP-response by TMS as an indicator of cortico-spinal tract integrity. Prognostic marker of motor recovery.
Time frame
Baseline4
TMS - Ipsilateral silent period (iSP)
Determination of degree of interhemispheric inhibition unaffected vs. affected hemisphere
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Christina Kruuse
Lead sponsor
Herlev Hospital
Sponsor institution
Danish Research Centre for Magnetic Resonance
Collaborator
The Novo Nordic Foundation
Collaborator
University of Copenhagen
Collaborator
Lundbeck Foundation
Collaborator
Source ClinicalTrials.gov