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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01983319
Enrollment
64
Registered
2013-11-13
Start date
2014-01-31
Completion date
2015-12-31
Last updated
2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

DEVICEactive anodal transcranial Direct Current Stimulation (tDCS)

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

DEVICEsham transcranial Direct Current Stimulation

sham transcranial Direct Current Stimulation 30 min with CIMT

Sponsors

Regionshospitalet Hammel Neurocenter
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Upper Limb functionBaseline and posttest (an average of 2 weeks from baseline)The motor function assessment will be done with: Wolf Motor Function Test

Secondary

MeasureTime frameDescription
GABA (gamma-aminobutyric acid) activityBaselineAssessment of GABA activity using MRI spectroscopy. Measurements will be compared between patients undergoing CIMT and healthy subjects.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026