Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients

Alexandria University

Status: Completed

Conditions: Spasticity, Muscle; Spastic; Stroke, Lacunar; Hemiplegic Gait; Stroke, Acute; Motor Activity; Hemiparesis; Hemiplegia; Stroke, Ischemic

Treatments: Device: Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04770363

0106522

Details and patient eligibility

About

This is a randomized clinical trial to study the effect of tDCS in participants with subacute ischemic stroke, the study participants will be randomly assigned into three groups; bihemispheric, unihemispheric and sham group.

Full description

Despite the central origin of stroke affecting the primary motor cortex M1, majority of the rehabilitative techniques of physical therapy and occupational therapy practice depending peripheral methods for gaining motor functions. There is a great need to develop methods in order to improve the outcome of physical or medical rehabilitation and enhance long-term functional outcome. Many researches' work over the past several years have inspected the use of transcranial direct current stimulation (tDCS) to promote the advantageous effect of neurological rehabilitation.

The aim of This study Is to compare between the effect of unihemispheric and bihemispheric tDCS on the motor outcome, and spasticity in sub-acute ischemic stroke patients.

Thirty sub-acute ischemic stroke patients participated in the study, randomly assigned to one of three groups-tDCS bihemispheric or unihemispheric or sham group. Those patients had stroke in the last 3 months at maximum with NIH stroke score less than 25. ActivaDose tDCS (USA), the only FDA cleared device available for tDCS used in the clinical study to deliver noninvasive brain stimulation, consisted of 20 minutes of 2 mA in each session for twelve sessions three sessions per week. All participants received physiotherapy and rehabilitation therapy was tailored to meet all patients' deficits, and lasted a total of 45 minutes per day, 3 days per week for four weeks.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Those patients had stroke in the last 3-6 months.
• Subcortical stroke of middle cerebral artery (MCA), caused unilateral hemiplegia.
• National institute of health stroke scale (NIHSS) motor deficits section with score 2 to 15.

Exclusion criteria

• Patient with second onset of stroke or history of Transient ischemic attack (TIA)
• Metallic Implant or heart pacemakers.
• Primary cerebral or subarachnoid hemorrhagic stroke.
• Seizure or epilepsy or history of epilepsy at the family.
• Intracranial abscess or brain tumor.
• Cardiovascular disease myocardial infarction, heart failure (unstable cardiac status).
• Atrial Fibrillation or paroxysmal AF in the last 30 days.
• Congenital heart diseases.
• Presence of any other neurological or psychiatric disorder.
• Cognitive/consciousness disorders.
• Oher conditions should be excluded (e.g. tumor, cancer, rheumatologic, Lung disease related to infection, renal/ hepatic diseases, deep venous thrombosis and autoimmune diseases).
• Speech disorders (Dysarthria & Aphasia).
• NIH Stroke score above 25, will be excluded.
• Patients who underwent thrombolytic therapy or any vascular interventions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups

Bihemispheric Stimulation Group

Experimental group

Description:

The first group tDCS bihemispheric stimulation consisted of 20 minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex M1 (C3 and C4 of the international 10 -20 EEG electrode system).

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Unihemispheric Stimulation Group

Experimental group

Description:

The second group unilateral stimulation, the anode placed over the ipsilesional motor cortex M1 (C3 or C4 of the international 10 -20 EEG electrode system) and the cathode over contralesional supraorbital bone.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Sham Group

Sham Comparator group

Description:

The third sham group, the anode placed over the ipsilesional motor cortex M1 (C3 or C4 of the international 10 -20 EEG electrode system) and the cathode over contralesional supraorbital bone, but delivering no current.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)