Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change in Upper Limb function
Study Overview
Brief Summary
The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •stroke onset >3 months prior to study enrollment
- •subject has at least 10 degrees mobility over wrist, thumb and fingers on the affected side
- •subject can move, stand up and stand firmly with constrained healthy hand
- •subject can perform training 6 hours daily in 2 weeks
- •subject is able to understand instructions and be able to cooperate
Exclusion Criteria
- •pregnancy
- •contraindications to MRI of brain
- •epilepsy, major psychiatric disease
- •excessive pain that prevents training
- •history of other diseases resulting decreased mobility of affected upper limb
Arms & Interventions
CIMT + active anodal tDCS
Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving active anodal transcranial Direct Current Stimulation 1,5 mA for 30 min.
Intervention: active anodal transcranial Direct Current Stimulation (tDCS) (Device)
CIMT + active anodal tDCS
Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving active anodal transcranial Direct Current Stimulation 1,5 mA for 30 min.
Intervention: Constraint Induced Movement Therapy (CIMT) (Behavioral)
CIMT + sham tDCS
Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving sham transcranial Direct Current Stimulation
Intervention: sham transcranial Direct Current Stimulation (Device)
CIMT + sham tDCS
Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving sham transcranial Direct Current Stimulation
Intervention: Constraint Induced Movement Therapy (CIMT) (Behavioral)
Healthy control subjects
20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain.
Outcomes
Primary Outcomes
Change in Upper Limb function
Time Frame: Baseline and posttest (an average of 2 weeks from baseline)
The motor function assessment will be done with: Wolf Motor Function Test
Secondary Outcomes
- GABA (gamma-aminobutyric acid) activity(Baseline)
Investigators
Krystian Figlewski
MD
University of Aarhus