Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke

Stroke Clinical Trial

Official title:

Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01311271
• Other study ID #: E-1011-056-003
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 4, 2011
• Last updated: May 18, 2015
• Start date: January 2011

Study information

• Verified date: May 2015
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

Description:

Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS.

The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• single mono-hemispheric ischemic or hemorrhagic stroke

• 1st onset stroke patient

• Upper extremity functional deficit attributable to acute stroke

• A stage of at least 3 on brunnström pre-treatment

• Written signed consent

Exclusion Criteria:

• Multiple lesion

• Bilateral cortical lesion and motor problems

• Cerebellar, or brainstem lesions

• History of more than one stroke

• Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;

• Increased intracranial pressure

• History of seizure confirmed by interview and medical chart review

• Any individual who is on medication which is known to lower seizure threshold

• Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family

• An age of less than 20 years old

• Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke

• Complications that would prevent participation in the intervention, such as severe pain and severe spasticity

• Inability to cooperate outcome measure-related task

• Severe language disturbances

• Serious cognitive deficits

• Non-vascular cause for the neurological symptoms other central nervous system

• Disorder or peripheral neuropathy of the upper extremity

• Taking medication which interrupt brain activity

• Women who are pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Device:
• repetitive transcranial magnetic stimulation (rTMS)
1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day, Real: unaffected M1 hotspot Sham: coil perpendicular to scalp

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Asan Medical Center, Gyeongsang National University Hospital, Hanyang University, Seoul National University Boramae Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Fugl-Meyer Assessment scale (upper extremity)		Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up	No
Secondary	Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage		Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up	No