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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
active anodal transcranial Direct Current Stimulation (tDCS)
sham transcranial Direct Current Stimulation
Constraint Induced Movement Therapy (CIMT)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Regionhospital Hammel Neurocenter, Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

CIMT + active anodal tDCS

CIMT + sham tDCS

Healthy control subjects

Arm 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.

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

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

Outcomes

Primary Outcome Measures

Change in Upper Limb function
The motor function assessment will be done with: Wolf Motor Function Test

Secondary Outcome Measures

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

Full Information

First Posted
October 31, 2013
Last Updated
February 4, 2017
Sponsor
University of Aarhus
Collaborators
Regionshospitalet Hammel Neurocenter, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01983319
Brief Title
tDCS Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
Official Title
Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Regionshospitalet Hammel Neurocenter, Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIMT + active anodal tDCS
Arm Type
Experimental
Arm 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 Title
CIMT + sham tDCS
Arm Type
Sham Comparator
Arm 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 Title
Healthy control subjects
Arm Type
No Intervention
Arm Description
20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain.
Intervention Type
Device
Intervention Name(s)
active anodal transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
tDCS, Non invasive brain stimulation, transcranial stimulation
Intervention Description
Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT
Intervention Type
Device
Intervention Name(s)
sham transcranial Direct Current Stimulation
Other Intervention Name(s)
placebo stimulation
Intervention Description
sham transcranial Direct Current Stimulation 30 min with CIMT
Intervention Type
Behavioral
Intervention Name(s)
Constraint Induced Movement Therapy (CIMT)
Other Intervention Name(s)
CIMT
Intervention Description
2 weeks of CIMT
Primary Outcome Measure Information:
Title
Change in Upper Limb function
Description
The motor function assessment will be done with: Wolf Motor Function Test
Time Frame
Baseline and posttest (an average of 2 weeks from baseline)
Secondary Outcome Measure Information:
Title
GABA (gamma-aminobutyric acid) activity
Description
Assessment of GABA activity using MRI spectroscopy. Measurements will be compared between patients undergoing CIMT and healthy subjects.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Andersen, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Regionhospital Hammel Neurocenter, Research Unit
City
Hammel
ZIP/Postal Code
8450
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
33175411
Citation
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.
Results Reference
derived
PubMed Identifier
27899754
Citation
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.
Results Reference
derived

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

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