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

NCT01983319 | Completed

• 1 other identifier: M-2013-268-13
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Upper Limb function

  The motor function assessment will be done with: Wolf Motor Function Test

  Baseline and posttest (an average of 2 weeks from baseline)

Secondary Outcomes (1)

• GABA (gamma-aminobutyric acid) activity

  Baseline

Study Arms (3)

CIMT + active anodal tDCS

EXPERIMENTAL

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.

Device: active anodal transcranial Direct Current Stimulation (tDCS); Behavioral: Constraint Induced Movement Therapy (CIMT)

CIMT + sham tDCS

SHAM COMPARATOR

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

Device: sham transcranial Direct Current Stimulation; Behavioral: Constraint Induced Movement Therapy (CIMT)

Healthy control subjects

NO INTERVENTION

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

Interventions

active anodal transcranial Direct Current Stimulation (tDCS) DEVICE

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

Also known as: tDCS, Non invasive brain stimulation, transcranial stimulation

CIMT + active anodal tDCS

sham transcranial Direct Current Stimulation DEVICE

sham transcranial Direct Current Stimulation 30 min with CIMT

Also known as: placebo stimulation

CIMT + sham tDCS

Constraint Induced Movement Therapy (CIMT) BEHAVIORAL

2 weeks of CIMT

Also known as: CIMT

CIMT + active anodal tDCS; CIMT + sham tDCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Regionshospitalet Hammel Neurocenter: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Regionhospital Hammel Neurocenter, Research Unit

Hammel, 8450, Denmark

Location

Related Publications (2)

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

  PMID: 33175411 DERIVED

• Figlewski K, Blicher JU, Mortensen J, Severinsen KE, Nielsen JF, Andersen H. Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. Stroke. 2017 Jan;48(1):229-232. doi: 10.1161/STROKEAHA.116.014988. Epub 2016 Nov 29.

  PMID: 27899754 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation; Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Exercise Therapy; Physical Therapy Modalities; Rehabilitation

Study Officials

• Henning Andersen, Professor

  Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 13, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

DK (1)