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Transcranial Direct Current Stimulation in Stroke Rehabilitation

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Application of Transcranial direct current stimulation (TDCS)
Transcranial Direct current stimulation
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, TDCS, Gait, Balance, loss of postural balance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients suffering from the consequences of a stroke in the medial cerebral artery, during the sub-acute phase (4-24 weeks after onset)
  2. Age between 18-75 years
  3. Hospitalised in rehabilitation Hospital Hof Ter Schelde
  4. Capable of understanding and giving informed consent

Exclusion Criteria:

  1. Cerebellum or brainstem lesions
  2. Recently multiple lesions and older lesions which are manifested clinically.
  3. History of severe substance abuse (alcohol, drugs, benzodiazepines)
  4. Cardiac disease that in the opinion of the clinician precludes participation in the trial (severe dyspnea in rest, severe rhythm disturbances, etc)
  5. History of epileptic insults, not caused by the stroke
  6. Severe organic co morbidity
  7. Psychiatric disorders or history of psychiatric disorders
  8. Pace maker / internal defibrillator
  9. Pregnancy

Sites / Locations

  • Rehabilitation Hospital Hof Ter ScheldeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

SHAM TDCS

True TDCS

Arm Description

Outcomes

Primary Outcome Measures

Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)
The static sitting balance subscale assesses whether a subject can sit independently and remain seated when the legs are either passively or actively crossed. The dynamic sitting balance subscale evaluates the ability to actively shorten each side of the trunk, first initiated from the shoulder and subsequently initiated from the pelvic girdle. Trunk coordination is evaluated by the possibility to independently rotate the upper and lower part of the trunk. The scoring range for the static and dynamic sitting balance and coordination subscales are 7, 10 and 6 points respectively.
Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months)
The RMAB assesses the motor performance of patients with stroke.32 It consists of test items clustered in three sections that are ordered hierarchically. The gross function subscale (13 items), the Leg and Trunk subscale (10 items) and the arm subscale (15 items)
Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months)
The Tinetti Test is an easily performed test that measures a patients' gait and balance. The individual scores are combined to form three measures; a gait score, a standing balance score and a total score. The maximum score for the gait component and the balance component are 12 and 16 points respectively, resulting in a maximum of 28 points for the total score.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2011
Last Updated
May 18, 2011
Sponsor
Universiteit Antwerpen
Collaborators
Rehabilitation Hospital Hof Ter Schelde, Artesis University College, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT01356654
Brief Title
Transcranial Direct Current Stimulation in Stroke Rehabilitation
Official Title
The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universiteit Antwerpen
Collaborators
Rehabilitation Hospital Hof Ter Schelde, Artesis University College, Antwerp

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.
Detailed Description
The patients were divided in 2 groups by a randomisation procedure. All patients participated for 2 months in the study. Group 1 received true tDCS in the first month followed by SHAM stimulation in the second month. Group 2 received SHAM in the first month and true stimulation in the following month. Four stimulations of 20minutes were provided during 4 weeks before before changing stimulation intensity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, TDCS, Gait, Balance, loss of postural balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHAM TDCS
Arm Type
Sham Comparator
Arm Title
True TDCS
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Application of Transcranial direct current stimulation (TDCS)
Other Intervention Name(s)
tDCS device: CESta, Mind Alive Inc.,Edmonton, Alberta, Canada
Intervention Description
Application of TDCS for 20 minutes, 4 times a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct current stimulation
Other Intervention Name(s)
tDCS device: CESta, Mind Alive Inc., Edmonton, Alberta, Canada
Intervention Description
Application of true TDCS for 20min, 4 times a week for 4 weeks.
Primary Outcome Measure Information:
Title
Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)
Description
The static sitting balance subscale assesses whether a subject can sit independently and remain seated when the legs are either passively or actively crossed. The dynamic sitting balance subscale evaluates the ability to actively shorten each side of the trunk, first initiated from the shoulder and subsequently initiated from the pelvic girdle. Trunk coordination is evaluated by the possibility to independently rotate the upper and lower part of the trunk. The scoring range for the static and dynamic sitting balance and coordination subscales are 7, 10 and 6 points respectively.
Time Frame
baseline, after 1 month, After 2 months
Title
Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months)
Description
The RMAB assesses the motor performance of patients with stroke.32 It consists of test items clustered in three sections that are ordered hierarchically. The gross function subscale (13 items), the Leg and Trunk subscale (10 items) and the arm subscale (15 items)
Time Frame
baseline, after 1 month, After 2 months
Title
Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months)
Description
The Tinetti Test is an easily performed test that measures a patients' gait and balance. The individual scores are combined to form three measures; a gait score, a standing balance score and a total score. The maximum score for the gait component and the balance component are 12 and 16 points respectively, resulting in a maximum of 28 points for the total score.
Time Frame
baseline, after 1 month, After 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from the consequences of a stroke in the medial cerebral artery, during the sub-acute phase (4-24 weeks after onset) Age between 18-75 years Hospitalised in rehabilitation Hospital Hof Ter Schelde Capable of understanding and giving informed consent Exclusion Criteria: Cerebellum or brainstem lesions Recently multiple lesions and older lesions which are manifested clinically. History of severe substance abuse (alcohol, drugs, benzodiazepines) Cardiac disease that in the opinion of the clinician precludes participation in the trial (severe dyspnea in rest, severe rhythm disturbances, etc) History of epileptic insults, not caused by the stroke Severe organic co morbidity Psychiatric disorders or history of psychiatric disorders Pace maker / internal defibrillator Pregnancy
Facility Information:
Facility Name
Rehabilitation Hospital Hof Ter Schelde
City
Antwerp
ZIP/Postal Code
2050
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Saeys, MSc
Phone
032106020
Email
wim.saeys@hotmail.com
First Name & Middle Initial & Last Name & Degree
Wim Saeys, Msc
First Name & Middle Initial & Last Name & Degree
Luc Vereeck, PhD
First Name & Middle Initial & Last Name & Degree
Christophe Lafosse, PhD

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

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Transcranial Direct Current Stimulation in Stroke Rehabilitation

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