Using Transcranial Magnetic Stimulation to Help Stroke Patients with Severe Arm Weakness

Effectiveness of Add-on Inhibitory Repetitive Transcranial Magnetic Stimulation Over the Contralesional Primary Motor Cortex in Subacute Stroke Patients With Severe Upper Limb Motor Impairment

This study is testing if a special brain stimulation treatment can help stroke patients with severe arm weakness improve their movement and daily activities.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Izmir Katip Celebi University (Academic / other)
• Locations: 1 site (İzmir)
• Trial ID: NCT05505201 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of inhibitory repetitive transcranial magnetic stimulation (rTMS) applied to the contralesional primary motor cortex in subacute stroke patients who have severe upper limb motor impairment. The research aims to assess improvements in motor function, daily living activities, and quality of life for patients who have experienced their first stroke within the last six months. By utilizing specific rTMS parameters, the study seeks to provide tailored rehabilitation interventions for individuals with significant upper limb deficits. The study will compare the effects of active rTMS against a sham treatment to determine its efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have experienced a first subcortical ischemic stroke affecting the middle cerebral artery within the last six months and have severe upper limb motor impairment.

Not a fit: Patients with contraindications to transcranial magnetic stimulation, such as those with metallic implants or a history of psychiatric illness, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve motor function and quality of life for stroke patients with severe upper limb impairment.

How similar studies have performed: Previous studies have shown promising results with similar rTMS approaches in stroke rehabilitation, particularly for patients with moderate to mild motor impairment, making this investigation a potentially novel contribution to the field.

Eligibility criteria

Inclusion Criteria:

* Presence of subcortical ischemic stroke affecting the middle cerebral artery territory, which has been confirmed by imaging methods
* Having a stroke for the first time
* Presence of subacute stroke (\< 6 months)
* Mini-mental test score ≥ 24
* Severe upper limb motor impairment (The Fugl-Meyer Assessment Scale - Upper Extremity motor impairment score ≤ 19/60, excluding reflex assessments)
* Lack of motor evoked potential (MEP) recording from the first dorsal interosseous muscle of the paretic extremity with single-pulse transcranial magnetic stimulation of the ipsilesional primary motor cortex (hand region)

Exclusion Criteria:

* To have a clinical condition (metallic implant, cardiac pace, pregnancy, breastfeeding, claustrophobia, epilepsy, head trauma, cranial operation history) that will constitute a contraindication to transcranial magnetic stimulation
* History of psychiatric illness such as major depression/personality disorder
* History of convulsion or epilepsy or taking medication for epilepsy
* Cognitive impairment
* Pregnancy or breastfeeding
* Alcohol or drug addiction
* Previously treated with transcranial magnetic stimulation
* Moderate or mild upper extremity motor impairment (The Fugl-Meyer Assessment Scale - Upper Extremity score \> 19/60, excluding reflex assessments)
* Presence of neglect

Where this trial is running

İzmir

• İlker Şengül — İzmir, Turkey (Recruiting)

Study contacts

• Principal investigator: İlker Şengül, M.D. — İzmir Katip çelebi University
• Study coordinator: İlker Şengül, M.D.

Conditions Stroke Rehabilitation; Stroke; Upper limb impairment; Repetitive transcranial magnetic stimulation