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

Stroke Clinical Trial

— TAMAS  

Official title:

A Randomized, Double-Blind, Sham-Controlled, Multi-center Clinical Trial to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients With Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082015
• Other study ID #: E-1308-214-002
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: February 28, 2018

Study information

• Verified date: September 2020
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 28, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Device:
• 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

Locations

Country	Name	City	State
Korea, Republic of	DongGuk University Ilsan Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	DongGuk University, REMED, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital Sign	Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start	up to 40 days
Primary	Box and Block Test (affected hand)	Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS	up to 17 days
Secondary	Box and Block Test (Affected and unaffected hand)	Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start	up to 40 days
Secondary	Barthel Index	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start	up to 40 days
Secondary	National Institutes of Health Stroke Scale	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start	up to 40 days
Secondary	Fugl-Meyer Assessment Scale	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start	up to 40 days
Secondary	Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start	up to 40 days
Secondary	Finger tapping	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start	up to 40 days
Secondary	B-stage (hand and arm)	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start	up to 40 days
Secondary	Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity)	10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start	up to 40 days