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NCT Number: NCT02082015

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DongGuk University Ilsan Hospital, Goyang-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low frequency rTMS

Device

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

Other names: TMS

Primary outcomes

  1. Box and Block Test (affected hand)

    Time frame: up to 17 days

    Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS

Secondary outcomes

  1. Box and Block Test (Affected and unaffected hand)

    Time frame: up to 40 days

    Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

  2. Barthel Index

    Time frame: up to 40 days

    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

  3. National Institutes of Health Stroke Scale

    Time frame: up to 40 days

    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

  4. Fugl-Meyer Assessment Scale

    Time frame: up to 40 days

    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

  5. Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)

    Time frame: up to 40 days

    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

  6. Finger tapping

    Time frame: up to 40 days

    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

  7. B-stage (hand and arm)

    Time frame: up to 40 days

    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

  8. Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity)

    Time frame: up to 40 days

    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

Other outcomes

  1. Vital Sign

    Time frame: up to 40 days

    Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • DongGuk University
  • REMED
  • Seoul National University Hospital

Registry information

Official study 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

Acronym: TAMAS

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2014
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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