Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients (TAMAS)

Seoul National University

Status: Completed

Conditions: Stroke; Hemiplegia

Treatments: Device: Low frequency rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT02082015

E-1308-214-002

Details and patient eligibility

About

The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke

Full description

Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact efficacy and safety of rTMS is not well established.

Eighty four patients will be recruited and will be divided into two groups. Each group will receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low frequency (1Hz), total 1800 stimulations.

The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper extremity motor function recovery in patients with ischemic stroke.

Enrollment: 77 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 20-80 yrs old
• Radiologically confirmed ischemic stroke within 90 days
• Brunnström stage 3-5 in the affected hand (ischemic stroke-induced hemiplegic side)
• Patients received stroke treatment and on secondary prevention medication
• Written informed consent

Exclusion criteria

• Previous medical histories of stroke, cerebral vascular operation, seizure
• Pregnancy, Breastfeeding
• Patients with hemorrhagic stroke, traumatic brain injury
• Skin lesion in the stimulation site of scalp
• Metal implants in the body (cardiac pacemaker or aneurysm clip)
• Unable to have regular physical and occupational therapies on the affected hand

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

77 participants in 2 patient groups

true coil

Experimental group

Description:

Use the true coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp

Treatment:

Device: Low frequency rTMS

sham coil

Sham Comparator group

Description:

Use the sham coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: vertical to scalp

Treatment:

Device: Low frequency rTMS