Effects of Bihemispheric Transcranial Direct Current Stimulation on Motor Function in Stroke Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-03-31

Brief Summary

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Motor impairment (impairment of movement) due to stroke is one of the leading disabilities in adults. In addition to established means of facilitating motor recovery after stroke such as physical and occupational therapy, a variety of experimental rehabilitation approaches have been tested. Although there have been significant advances in stroke rehabilitation with these techniques and treatments, research on this subject is continuing. Recent studies have focused on non-invasive brain stimulation techniques. Transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) therapies, which are methods of non-invasive brain stimulation that may be effective on cerebral remodelling, aim to reestablish the disturbed balance between the anatomic areas of the brain seen in stroke patients.

The primary aim of this study is to evaluate the effectiveness of bihemispheric transcranial direct current stimulation (tDCS) applications on the upper extremity motor functions of patients with stroke.

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Detailed Description

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Motor impairment due to ischemic and hemorrhagic stroke is one of the leading disabilities in adults. In addition to established means of facilitating motor recovery after stroke such as physical and occupational therapy, a variety of experimental rehabilitation approaches have been tested. Recent developments include noninvasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The use of these tools is based on neurophysiologic studies demonstrating an imbalance of interhemispheric interactions which appears to interfere with the recovery process.

The model of interhemispheric imbalance provides a framework for developing hypotheses based on its 2 facets: 1) upregulating excitability of intact portions of the ipsilesional motor cortex and 2) downregulating excitability of the contralesional motor cortex to modulate its unrestrained inhibitory influence on ipsilesional regions. Studies to date have shown have shown the beneficial effects of tDCS on motor skills and motor learning.

Bihemispheric tDCS may potentiate the effects of anodal stimulation to the lesional hemisphere through additional modulation of interhemispheric interactions via cathodal stimulation to the contralesional motor cortex.

The primary aim of this prospective, randomized, sham controlled study is to evaluate the effectiveness of bihemispheric transcranial direct current stimulation (tDCS) applications on the upper extremity motor functions of patients with stroke.

Conditions

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Stroke Upper Extremity Paresis Transcranial Direct Current Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The aim of the study is to evaluate and compare the effect of tDCS plus conventional physiotherapy and occupational therapy to sham tDCS plus conventional physiotherapy and occupational therapy on upper extremity motor function in patients with subacute stroke was aimed in our study.

32 patients will be randomly assigned to one of two groups in parallel for the duration of the study: bihemispheric tDCS (n:16), or sham tDCS (n:16). In addition to a conventional physiotherapy and occupational therapy program, bihemispheric tDCS application will be applied to one group and sham tDCS applied to the second group. A constant current stimulator(ZMI Electronics Limited,Taiwan,2012) will be used for the application of tDCS. In both groups, the tDCS application will be started simultaneously with the occupational therapy session and will last for thirty minutes.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tDCS group

Sixteen stroke patient receiving bihemispheric tDCS in addition to a conventional physiotherapy (PT) and occupational therapy (OT) program for five consecutive days per week for a three week period (a total of fifteen sessions).

The one hour long conventional PT sessions will include an upper extremity range of motion, strengthening and neurofacilitation exercise program. The one hour long OT sessions will include task specific exercises chosen according to the patient's functional status, including activities aimed at improving gross and fine motor function of the upper extremities.

The tDCS application will be applied at the beginning of each OT session and will be continued for a total of thirty minutes at 2 mA.

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

A constant current stimulator (ZMI Electronics LTD.,Taiwan,2012) will be used through 2 saline-soaked surface gel-sponge electrodes (22 cm2 active area). Real stimulation consisting of thirty minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex (C3 and C4 of the international 10-20 EEG electrode system).

Sham group

Sixteen stroke patient receiving a conventional PT and OT program and sham tDCS for 5 consecutive days per week for a 3 week period ( a total of 15 sessions). The one hour long conventional PT and OT sessions will be the same as in the tDCS group. For sham tDCS, electrode application and positioning will be the same as the intervention group and will be applied at the beginning of each OT session as previously described. The current will initially be increased up to 2 mA, so to provide the typical initial tingling sensation, and slowly decreased over 30 seconds and consequently switched off. The electrodes will be removed after a total of thirty minutes.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

For sham tDCS, the same electrode positions were used. The current was ramped up to 2 mA and slowly decreased over 30 seconds to ensure the typical initial tingling sensation

Interventions

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tDCS

A constant current stimulator (ZMI Electronics LTD.,Taiwan,2012) will be used through 2 saline-soaked surface gel-sponge electrodes (22 cm2 active area). Real stimulation consisting of thirty minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex (C3 and C4 of the international 10-20 EEG electrode system).

Intervention Type DEVICE

sham tDCS

For sham tDCS, the same electrode positions were used. The current was ramped up to 2 mA and slowly decreased over 30 seconds to ensure the typical initial tingling sensation

Intervention Type DEVICE

Other Intervention Names

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Conventional physiotherapy and occupational therapy Conventional physiotherapy and occupational therapy

Eligibility Criteria

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Inclusion Criteria

1. 18-75 years old, female or male
2. Clinical evaluation consistent with hemiplegia
3. First time stroke with brain computerized tomography (CT) and / or magnetic resonance imaging (MRI) findings consistent with stroke
4. At least 3 months since stroke onset
5. Presence of a stable medical condition
6. Preserved cognitive function as determined by a mini mental state examination score of 23 and above

Exclusion Criteria

1. Presence of a sensory aphasia
2. Presence of neglect syndrome
3. A history of epilepsy
4. Presence of a pacemaker
5. Previous history of stroke
6. History of previous cranial surgery
7. Presence of a brain tumour
8. Presence of an intracranial metallic implant
9. Marked hearing / visual impairment
10. Presence of severe spasticity (grade 3-4 according to the modified Ashworth scale)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No