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NCT Number: NCT06482372

A Pilot Study of Repetitive Transcranial Magnetic Stimulation

Stroke patients often have long-term upper limb dysfunction. Currently, there is still no specific clinical treatment for nerve damage. After acute treatments of stroke, patients' motor ability can only improve by spontaneous recovery of brain and rehabilitation treatment.

Transcranial magnetic stimulation uses a magnetic field pulse generated by a coil outside the skull to pass through the skull. It uses the principle that magnetic electricity can generate currents, which activates nearby brain areas or changing the relationship between the left and right brains. Transcranial magnetic stimulation is a non-invasive, safe treatment.

Mirror therapy is an emerging rehabilitation method in recent years. As mirror therapy, therapists ask the patient to place the affected hand behind the mirror while looking at the image reflected by the unaffected upper limb. During mirror therapy, patients have to perform upper limb activities and imagine that the affected upper limb is performing the same action.

As mentioned above, transcranial magnetic stimulation and mirror therapy improve the recovery of stroke patients by two different ways. Currently, there are no studies that combine these two treatments. Therefore, our study hopes to initially explore the efficacy of transcranial magnetic stimulation and the efficacy of transcranial magnetic stimulation combined with mirror therapy.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mirror Therapy Nervous System Diseases Transcranial Magnetic Stimulation Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • at least 1 month after stroke
  • manual muscle strength < 5

Exclusion criteria

  • history of epilepsy
  • has other central nervous system diseases
  • has electric medication pump
  • has implant at inner ear

Treatment and study plan

Transcranial Magnetic Stimulation

Device

repetitive transcranial magnetic stimulation at both cerebral hemisphere

Other names: mirror therapy

Primary outcomes

  1. Fugl-Meyer Assessment (FMA) - upper extremity

    Time frame: week 0, week 6, week 12

    FMA would be recorded for evaluate patients' motor function of hand.

  2. Nine-hole peg test

    Time frame: week 0, week 6, week 12

    Nine-hole peg test would be used to measure finger dexterity.

  3. Action research arm test

    Time frame: week 0, week 6, week 12

    Action research arm test would be used to assess upper extremity performance including coordination, dexterity and functioning.

  4. Box and block test

    Time frame: week 0, week 6, week 12

    Box and block test would be used to assess unilateral gross manual dexterity.

  5. Functional independence measurement

    Time frame: week 0, week 6, week 12

    Functional independence measurement would be recorded to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Jou Yu Lin

CONTACT

[email protected]

+886-2-28264400 ext. 3806

Sponsors and collaborators

Lead sponsor

Cheng-Hsin General Hospital

Other

Registry information

Official study title

Effects of Repetitive Transcranial Magnetic Stimulation Combined With Mirror Therapy on Upper Limb Function in Patients With Stroke: a Pilot Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2024
Registry last updated
Jul 1, 2024

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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