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

NCT ID: NCT01311271

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31

Brief 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.

Detailed 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.

Conditions

Stroke; Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham rTMS-Sham rTMS

Sham rTMS for 2 weeks

Group Type: SHAM_COMPARATOR

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

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

Sham rTMS-Real rTMS

Sham rTMS in the first week and real rTMS in the second week

Group Type: EXPERIMENTAL

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

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

Real rTMS-Real rTMS

Real rTMS for 2 weeks

Group Type: EXPERIMENTAL

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

TAMAS

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: collaborator

Gyeongsang National University Hospital

OTHER

Sponsor Role: collaborator

Hanyang University

OTHER

Sponsor Role: collaborator

Seoul National University Boramae Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nam-Jong Paik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nam-Jong Paik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

E-1011-056-003

Identifier Type: -

Identifier Source: org_study_id