StrokeNCT06482372
A Pilot Study of Repetitive Transcranial Magnetic Stimulation
A study testing transcranial magnetic stimulation in people with Stroke and Mirror Therapy, run by Cheng-Hsin General Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke, Mirror Therapy, Transcranial Magnetic Stimulation
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 1 month after stroke
- manual muscle strength < 5
Who cannot join
- history of epilepsy
- has other central nervous system diseases
- has electric medication pump
- has implant at inner ear
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Repetitive Transcranial Magnetic Stimulation Combined With Mirror Therapy on Upper Limb Function in Patients With Stroke: a Pilot Study
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.
Read more
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.
- Conditions
- Stroke, Mirror Therapy, Transcranial Magnetic Stimulation
- Being tested
- transcranial magnetic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
Also called mirror therapy
repetitive transcranial magnetic stimulation at both cerebral hemisphere
| Study group | Role | What they receive |
|---|---|---|
| rTMS + mirror therapy + traditional OT | Experimental | Patient would receive treatment three time per week, including individualized rTMS, and following mirror therapy and traditional occupational therapy. Receives: Device: transcranial magnetic stimulation |
| rTMS + traditional OT | Active comparator | Patient would receive treatment three time per week, including individualized rTMS and following traditional occupational therapy. Receives: Device: transcranial magnetic stimulation |
| sham rTMS + traditional OT | Placebo comparator | Patient would receive treatment three time per week, including sham rTMS and following traditional occupational therapy. Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA) - upper extremity
FMA would be recorded for evaluate patients' motor function of hand.
Measured: week 0, week 6, week 12
Nine-hole peg test
Nine-hole peg test would be used to measure finger dexterity.
Measured: week 0, week 6, week 12
Action research arm test
Action research arm test would be used to assess upper extremity performance including coordination, dexterity and functioning.
Measured: week 0, week 6, week 12
Box and block test
Box and block test would be used to assess unilateral gross manual dexterity.
Measured: week 0, week 6, week 12
Functional independence measurement
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.
Measured: week 0, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482372
- Sponsor's protocol ID
- (1055)112A-46
- Status last verified
- Jun 2024
- First submitted
- 17 Mar 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation Combined With Mirror Therapy on Upper Limb Function in Patients With Stroke: a Pilot Study
- ClinicalTrials.gov ID
- NCT06482372
- Acronym / sponsor ID
- (1055)112A-46
- Conditions
- Stroke, Mirror Therapy, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rTMS + mirror therapy + traditional OT | Experimental | Device: transcranial magnetic stimulationPatient would receive treatment three time per week, including individualized rTMS, and following mirror therapy and traditional occupational therapy. |
| rTMS + traditional OT | Active comparator | Device: transcranial magnetic stimulationPatient would receive treatment three time per week, including individualized rTMS and following traditional occupational therapy. |
| sham rTMS + traditional OT | Placebo comparator | Device: transcranial magnetic stimulationPatient would receive treatment three time per week, including sham rTMS and following traditional occupational therapy. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 1 month after stroke
- manual muscle strength < 5
Key exclusion criteria (4 listed)
- history of epilepsy
- has other central nervous system diseases
- has electric medication pump
- has implant at inner ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationAlso: mirror therapyrepetitive transcranial magnetic stimulation at both cerebral hemisphere | Device | rTMS + mirror therapy + traditional OT, rTMS + traditional OT, sham rTMS + traditional OT |
Primary outcome
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.
Nine-hole peg test
Time frame: week 0, week 6, week 12
Nine-hole peg test would be used to measure finger dexterity.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Stroke and Mirror Therapy, run by Cheng-Hsin General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jou Yu Lin (+886-2-28264400 ext. 3806, trancequid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) - upper extremity (time frame: week 0, week 6, week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.