Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery

tDCS Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery

Sponsors

Lead sponsor: University of Aarhus

Collaborator: Regionshospitalet Hammel Neurocenter
Aarhus University Hospital

Source University of Aarhus
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.

Overall Status Completed
Start Date January 2014
Completion Date December 2015
Primary Completion Date December 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Upper Limb function Baseline and posttest (an average of 2 weeks from baseline)
Secondary Outcome
Measure Time Frame
GABA (gamma-aminobutyric acid) activity Baseline
Enrollment 64
Condition
Intervention

Intervention type: Device

Intervention name: active anodal transcranial Direct Current Stimulation (tDCS)

Description: Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT

Arm group label: CIMT + active anodal tDCS

Intervention type: Device

Intervention name: sham transcranial Direct Current Stimulation

Description: sham transcranial Direct Current Stimulation 30 min with CIMT

Arm group label: CIMT + sham tDCS

Other name: placebo stimulation

Intervention type: Behavioral

Intervention name: Constraint Induced Movement Therapy (CIMT)

Description: 2 weeks of CIMT

Other name: CIMT

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Henning Andersen, Professor Study Director Aarhus University Hospital
Location
facility
Regionhospital Hammel Neurocenter, Research Unit
Location Countries

Denmark

Verification Date

February 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Aarhus

Investigator full name: Krystian Figlewski

Investigator title: MD

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: CIMT + active anodal tDCS

Arm group type: Experimental

Description: 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.

Arm group label: CIMT + sham tDCS

Arm group type: Sham Comparator

Description: 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

Arm group label: Healthy control subjects

Arm group type: No Intervention

Description: 20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Care Provider)

Source: ClinicalTrials.gov