Transcranial Direct Current Stimulation in Stroke Rehabilitation

NCT ID: NCT01356654

Last Updated: 2011-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-06-30

Brief Summary

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This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SHAM TDCS

Group Type SHAM_COMPARATOR

Application of Transcranial direct current stimulation (TDCS)

Intervention Type DEVICE

Application of TDCS for 20 minutes, 4 times a week for 4 weeks.

True TDCS

Group Type ACTIVE_COMPARATOR

Transcranial Direct current stimulation

Intervention Type DEVICE

Application of true TDCS for 20min, 4 times a week for 4 weeks.

Interventions

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Application of Transcranial direct current stimulation (TDCS)

Application of TDCS for 20 minutes, 4 times a week for 4 weeks.

Intervention Type DEVICE

Transcranial Direct current stimulation

Application of true TDCS for 20min, 4 times a week for 4 weeks.

Intervention Type DEVICE

Other Intervention Names

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tDCS device: CESta, Mind Alive Inc.,Edmonton, Alberta, Canada tDCS device: CESta, Mind Alive Inc., Edmonton, Alberta, Canada

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rehabilitation Hospital Hof Ter Schelde

UNKNOWN

Sponsor Role collaborator

Artesis University College, Antwerp

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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UZA

Locations

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Rehabilitation Hospital Hof Ter Schelde

Antwerp, Antwerp, Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Wim Saeys, MSc

Role: primary

032106020

References

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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.

Reference Type DERIVED
PMID: 33175411 (View on PubMed)

Other Identifiers

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Saeys-1

Identifier Type: -

Identifier Source: org_study_id

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