Effect of repetitive transcranial magnetic stimulation on upper limb motor function and cortical excitability in stroke patients

Phase 3

Recruiting

• Conditions: Nervous System Diseases; Stroke

• Registration Number: PACTR201807106955779
• Lead Sponsor: Faculty of physical therapy Cairo university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-29
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

a)30 matched hemiparetic stroke patients aging between 50-65 years.

b)Patients with ischemic stroke in the territory of the middle cerebral artery confirmed by physician with non-contrast computed tomographic (CT) or magnetic resonance imaging (MRI) scans of the brain.

c)Mild to moderate upper-limb motor impairment verified according to (National Institutes of Health Stroke Scale [NIHSS]¿motor arm score of 1 to 15, and modified ashwarth¿s scale (1 or 1+)

d)Time from onset of symptoms 3 to 6 months ( Du et al,2016).

e)Stable vital signs with clear consciousness and proper cooperation with assessment and treatment.

f)Successful measurement of motor-evoked potential (MEP) from the contralesional primary motor cortex (M1).

g)The medical ethical committee from faculty of physical therapy, Cairo university will approve the project of the study.

h)All the patients or their families will be given their written consent form.

Exclusion Criteria

a)Patients who undergo surgical management including intravascular surgery or administration of tissue plasminogen activator .

b)Patients with disturbance of consciousness (a score of eye opening of 4 and best verbal response of 5 on the Glasgow Coma Scale).

c)Patients with aphasia or apparent cognitive deficits ( as hand apraxia, unilateral spatial neglect) , visual field deficits or any psychiatric disorders.

d)Patients with serious general complications requiring intensive medical management (eg, pneumonia severe internal carotid artery stenosis or bilateral cerebrovascular lesion, heart failure, urinary tract infection, or mal nutritional state).

e)Patients with other neurological or severe chronic diseases; ex: shoulder pain; joint deformity or complete paralysis of the affected upper limb .

f)Patients with pathologic conditions or any contraindications for rTMS in the guidelines (eg, patients with metal within the brain, such as clips for aneurysms, patients with a cardiac pacemaker, pregnant women, or a history of seizures or epilepsy) .

g)Patients with history of head injury with loss of consciousness.

h)Use of any drugs that could have an effect on cortical excitability (ex. Antiepileptic drugs) .

i)Patients previously undergo any type of treatments using transcranial magnetic stimulation .

j)Refusal to sign the informed consent or could not carry out training or cooperate with assessments.

Study & Design

• Study Type: Interventional
• Study Design: Not specified