Intracerebral HemorrhageNCT05920473
Efficacy and Safety Study: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH).
A study testing rTMS with Magstim Rapid 2 magnetic stimulation device in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 3 sites in China.
Trial summary
This pilot study aims to assess the effectiveness and safety of rTMS in the treatment of movement disorders in patients with ICH. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- rTMS with Magstim Rapid 2 magnetic stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants between the ages of 45 and 65 years old.
- More than 1 month and less than 3 months after ICH
- With severe and moderately severe motor functional impairment, indicated by a Functional Motor Assessment (FMA) score ranging from 0 to 55.
- Unilateral basal ganglia hemorrhage with a hematoma volume of 30-60ml, measured using the ABC2 method based on preoperative CT scans.
- Participants should have a stable level of consciousness, with a score of 0 to 1 on the level of consciousness, level of consciousness questions, and level of consciousness instructions of the National Institutes of Health Stroke Scale (NIHSS), along with stable vital signs.
- Underwent surgical treatment for ICH within 2 weeks after the event, utilizing either craniotomy or endoscopic hematoma evacuation, with an evacuation rate of at least 80%.
- Signed the informed consent.
Who cannot join
- With a history of epilepsy.
- With movement disorders resulting from causes other than basal ganglia hemorrhage.
- With severe general impairment or coexisting medical conditions.
- With emotional issues or cognitive impairments, as indicated by a Mini-Mental State Examination (MMSE) score below 21.
- With any contraindications to transcranial magnetic stimulation (TMS), such as having metal implants in the brain or using a pacemaker.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Yong Cao, M.D., +86(010)59976510 ext. 100070, caoyong@bjtth.org
Shaozhi Zhao, M.D., 18801217693 ext. 100070, sdsgzsz@163.com
- Recruiting
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
Beijing
Xianwei Zeng, M.D., +86 15810000385, zengxwei@163.com
- Recruiting
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen
Zhiwei Wang, M.D.
About this study
Official title: Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH): A Randomized, Blinded, Sham-controlled Trial.
This pilot study aims to assess the effectiveness and safety of rTMS in the treatment of movement disorders in patients with ICH.
Read the detailed description
While the fatality rate of intracerebral hemorrhage (ICH) has decreased, many patients continue to experience persistent limb movement dysfunction. Motor dysfunction in ICH is commonly attributed to basal ganglia hemorrhage, as the basal ganglia play a central role in the extrapyramidal motor system. Therefore, promoting the remodeling of the extrapyramidal motor system holds great significance for effectively treating ICH patients with movement disorders.
Repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive neuromodulation technique that can modulate neuronal activity, influence neuronal synaptic plasticity, and enhance brain function. Currently, rTMS has shown promise in improving motor function among patients with stroke and those who have undergone brain tumor surgery, which provides valuable insights for its potential application in patients with motor dysfunction following ICH surgery.
This pilot study aims to evaluate the efficacy and safety of rTMS in the treatment of ICH patients with movement disorders. The participants will be randomly assigned to either a real rTMS treatment group or a sham group. The study will assess and compare various clinical outcomes, including the FMA (Fugl-Meyer Assessment), NIHSS (National Institutes of Health Stroke Scale), and BI (Barthel Index) scores, over a period of 6 months.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- rTMS with Magstim Rapid 2 magnetic stimulation device, sham control with Magstim Rapid 2 magnetic stimulation device
- Keywords
- Intracerebral Hemorrhage, Movement Disorders, Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Cerebral Hemorrhage, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS with Magstim Rapid 2 magnetic stimulation deviceDevice
The study will involve the utilization of the Magstim Rapid 2 magnetic stimulation device to administer rTMS treatment to the participants. The coil will be positioned tangentially on the scalp, specifically targeting the hot spot (thumb movement area) in the ipsilateral cerebral hemisphere. During the stimulation protocol, a 10-Hz stimulation will be applied for 2 seconds, followed by a 10-second rest period. This cycle will be repeated 50 times. The treatment will be administered once daily, from Monday to Friday, for a continuous period of two weeks.
sham control with Magstim Rapid 2 magnetic stimulation deviceDevice
In the sham group, patients received sham stimulation using the the Magstim Rapid 2 magnetic stimulation device with the same protocol. The coil was positioned to target the same hot spot, with an angulation parallel to the gyrus to further reduce the potential impact of rTMS.
| Study group | Role | What they receive |
|---|---|---|
| rTMS intervention group | Experimental | Participants will undergo rTMS treatment using the Magstim Rapid 2 magnetic stimulation device. The coil was placed positioned tangentially on the scalp, targeting the hot spot (thumb movement area) in the ipsilateral cerebral hemisphere. The stimulation protocol will involve 10-Hz stimulation for 2 seconds, followed by a followed by a 10-second rest, which was repeated 50 times. Patients will receive treatment once a day, five days a week (Monday to Friday), for a total of two consecutive weeks. Receives: Device: rTMS with Magstim Rapid 2 magnetic stimulation device |
| Sham group | Sham comparator | Patients in the sham group underwent sham stimulation using the Magstim Rapid 2 magnetic stimulation device with the same protocol. The coil was positioned to target the same hot spot, with an angulation parallel to the gyrus to the gyrus in order to additionally minimize the rTMS effect. Receives: Device: sham control with Magstim Rapid 2 magnetic stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment (FMA)
Motor function was evaluated using the FMA, a scale ranging from 0 to 100 that measures movement ability. Higher scores reflect better motor function. The outcome measure assesses the change in the FMA score at 6 months compared to baseline.
Measured: Month 6
Secondary outcomes (6)
Change in Fugl-Meyer Assessment (FMA)
Motor function was evaluated using the FMA, a scale ranging from 0 to 100 that measures movement ability. Higher score reflect better motor function. The outcome measure assesses the change in the FMA score at 1 day, 1month, and 3 months compared to baseline.
Measured: Day 1, Month 1, Month 3
Fugl-Meyer Assessment (FMA) Response
Motor function was assessed using the FMA, which utilizes a scale ranging from 0 to 100. Higher scores indicate improved movement function, and an increase of 10 or more points in the FMA is considered a significant improvement. The response rate of the FMA was calculated at 1 day, 1 month, 3 months, and 6 months following therapy.
Measured: baseline, Day 1, Month 1, Month 3, Month 6
Change in Fugl-Meyer Assessment, Upper Limb (FMA-UL)
Motor function of upper limb was evaluated using the FMA-UL, a scale ranging from 0 to 66 that measures upper limb movement ability. Higher score reflect better motor function. The outcome measure assesses the change in the FMA-UL score at 1 day, 1month, 3 months, and 6 months compared to baseline.
Measured: Day 1, Month 1, Month 3, Month 6
Change in Fugl-Meyer Assessment, Lower Limb (FMA-LL)
Motor function of lower limb was evaluated using the FMA-LL, a scale ranging from 0 to 34 that measures lower limb movement ability. Higher score reflect better motor function. The outcome measure assesses the change in the FMA-LL score at 1 day, 1month, 3 months, and 6 months compared to baseline.
Measured: Day 1, Month 1, Month 3, Month 6
Change in Barthel Index (BI) score
The activities of daily living was evaluated using the BI scores, which is a scale ranging from 0 to 100. Higher score reflect better motor function. The outcome measure assesses the change in the BI score at 1 day, 1month, 3 months, and 6 months compared to baseline.
Measured: Day 1, Month 1, Month 3, Month 6
Change in NIH stroke scale (NIHSS) score
The stroke impairment was evaluated using the NIHSS, which is a scale ranging from 0 to 42. Higher score reflect worse function. The outcome measure assesses the change in the NIH stroke scale score at 1 day, 1month, 3 months, and 6 months compared to baseline.
Measured: Day 1, Month 1, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Nanshan District Shekou People's Hospital
- Responsible party
- Principal investigator, Dr. Yong Cao, Beijing Tiantan Hospital
- Investigators
- Yong Cao, M.D., Principal investigator, Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920473
- Sponsor's protocol ID
- ICH-rTMS
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH): A Randomized, Blinded, Sham-controlled Trial.
- ClinicalTrials.gov ID
- NCT05920473
- Acronym / sponsor ID
- ICH-rTMS
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Movement Disorders, Repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Nanshan District Shekou People's Hospital
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jun 2023 (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.
This pilot study aims to assess the effectiveness and safety of rTMS in the treatment of movement disorders in patients with ICH.
Detailed description
While the fatality rate of intracerebral hemorrhage (ICH) has decreased, many patients continue to experience persistent limb movement dysfunction. Motor dysfunction in ICH is commonly attributed to basal ganglia hemorrhage, as the basal ganglia play a central role in the extrapyramidal motor system. Therefore, promoting the remodeling of the extrapyramidal motor system holds great significance for effectively treating ICH patients with movement disorders.
Repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive neuromodulation technique that can modulate neuronal activity, influence neuronal synaptic plasticity, and enhance brain function. Currently, rTMS has shown promise in improving motor function among patients with stroke and those who have undergone brain tumor surgery, which provides valuable insights for its potential application in patients with motor dysfunction following ICH surgery.
This pilot study aims to evaluate the efficacy and safety of rTMS in the treatment of ICH patients with movement disorders. The participants will be randomly assigned to either a real rTMS treatment group or a sham group. The study will assess and compare various clinical outcomes, including the FMA (Fugl-Meyer Assessment), NIHSS (National Institutes of Health Stroke Scale), and BI (Barthel Index) scores, over a period of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS intervention group | Experimental | Device: rTMS with Magstim Rapid 2 magnetic stimulation deviceParticipants will undergo rTMS treatment using the Magstim Rapid 2 magnetic stimulation device. The coil was placed positioned tangentially on the scalp, targeting the hot spot (thumb movement area) in the ipsilateral cerebral hemisphere. The stimulation protocol will involve 10-Hz stimulation for 2 seconds, followed by a followed by a 10-second rest, which was repeated 50 times. Patients will receive treatment once a day, five days a week (Monday to Friday), for a total of two consecutive weeks. |
| Sham group | Sham comparator | Device: sham control with Magstim Rapid 2 magnetic stimulation devicePatients in the sham group underwent sham stimulation using the Magstim Rapid 2 magnetic stimulation device with the same protocol. The coil was positioned to target the same hot spot, with an angulation parallel to the gyrus to the gyrus in order to additionally minimize the rTMS effect. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants between the ages of 45 and 65 years old.
- More than 1 month and less than 3 months after ICH
- With severe and moderately severe motor functional impairment, indicated by a Functional Motor Assessment (FMA) score ranging from 0 to 55.
- Unilateral basal ganglia hemorrhage with a hematoma volume of 30-60ml, measured using the ABC2 method based on preoperative CT scans.
- Participants should have a stable level of consciousness, with a score of 0 to 1 on the level of consciousness, level of consciousness questions, and level of consciousness instructions of the National Institutes of Health Stroke Scale (NIHSS), along with stable vital signs.
Key exclusion criteria (5 listed)
- With a history of epilepsy.
- With movement disorders resulting from causes other than basal ganglia hemorrhage.
- With severe general impairment or coexisting medical conditions.
- With emotional issues or cognitive impairments, as indicated by a Mini-Mental State Examination (MMSE) score below 21.
- With any contraindications to transcranial magnetic stimulation (TMS), such as having metal implants in the brain or using a pacemaker.
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 |
|---|---|---|
| rTMS with Magstim Rapid 2 magnetic stimulation deviceThe study will involve the utilization of the Magstim Rapid 2 magnetic stimulation device to administer rTMS treatment to the participants. The coil will be positioned tangentially on the scalp, specifically targeting the hot spot (thumb movement area) in the ipsilateral cerebral hemisphere. During the stimulation protocol, a 10-Hz stimulation will be applied for 2 seconds, followed by a 10-second rest period. This cycle will be repeated 50 times. The treatment will be administered once daily, from Monday to Friday, for a continuous period of two weeks. | Device | rTMS intervention group |
| sham control with Magstim Rapid 2 magnetic stimulation deviceIn the sham group, patients received sham stimulation using the the Magstim Rapid 2 magnetic stimulation device with the same protocol. The coil was positioned to target the same hot spot, with an angulation parallel to the gyrus to further reduce the potential impact of rTMS. | Device | Sham group |
Primary outcome
Change in Fugl-Meyer Assessment (FMA)
Time frame: Month 6
Motor function was evaluated using the FMA, a scale ranging from 0 to 100 that measures movement ability. Higher scores reflect better motor function. The outcome measure assesses the change in the FMA score at 6 months compared to baseline.
6 secondary outcomes
Change in Fugl-Meyer Assessment (FMA)
Time frame: Day 1, Month 1, Month 3
Fugl-Meyer Assessment (FMA) Response
Time frame: baseline, Day 1, Month 1, Month 3, Month 6
Change in Fugl-Meyer Assessment, Upper Limb (FMA-UL)
Time frame: Day 1, Month 1, Month 3, Month 6
Change in Fugl-Meyer Assessment, Lower Limb (FMA-LL)
Time frame: Day 1, Month 1, Month 3, Month 6
Change in Barthel Index (BI) score
Time frame: Day 1, Month 1, Month 3, Month 6
Change in NIH stroke scale (NIHSS) score
Time frame: Day 1, Month 1, Month 3, Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yong Cao, M.D. principal investigator
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS with Magstim Rapid 2 magnetic stimulation device in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 3 sites in China.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Cao, M.D. (+86(010)59976510 ext. 100070, caoyong@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment (FMA) (time frame: Month 6). 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 27 Jun 2023.