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Efficacy and Safety Study: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH).

Primary Purpose

Intracerebral Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rTMS with Magstim Rapid 2 magnetic stimulation device
sham control with Magstim Rapid 2 magnetic stimulation device
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Intracerebral Hemorrhage, Movement Disorders, Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting
  • Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical AidsRecruiting
  • Shenzhen Qianhai Shekou Free Trade Zone HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

rTMS intervention group

Sham group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 4, 2023
Last Updated
June 17, 2023
Sponsor
Beijing Tiantan Hospital
Collaborators
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Qianhai Shekou Free Trade Zone Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05920473
Brief Title
Efficacy and Safety Study: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH).
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Qianhai Shekou Free Trade Zone Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Intracerebral Hemorrhage, Movement Disorders, Repetitive Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS with Magstim Rapid 2 magnetic stimulation device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham control with Magstim Rapid 2 magnetic stimulation device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment (FMA)
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment (FMA)
Description
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.
Time Frame
Day 1, Month 1, Month 3
Title
Fugl-Meyer Assessment (FMA) Response
Description
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.
Time Frame
baseline, Day 1, Month 1, Month 3, Month 6
Title
Change in Fugl-Meyer Assessment, Upper Limb (FMA-UL)
Description
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.
Time Frame
Day 1, Month 1, Month 3, Month 6
Title
Change in Fugl-Meyer Assessment, Lower Limb (FMA-LL)
Description
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.
Time Frame
Day 1, Month 1, Month 3, Month 6
Title
Change in Barthel Index (BI) score
Description
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.
Time Frame
Day 1, Month 1, Month 3, Month 6
Title
Change in NIH stroke scale (NIHSS) score
Description
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.
Time Frame
Day 1, Month 1, Month 3, Month 6
Other Pre-specified Outcome Measures:
Title
Changes in the structural brain network connectivity
Description
Using Diffusion Tensor Imaging (DTI) to assess the connectivity of the brain structural network, DTI reveals the connectivity by measuring the diffusion direction and rate of water molecules in the tissue. Based on DTI, the changes in the connectivity of the brain structural network are compared between 6 months after treatment and the baseline level.
Time Frame
Month 6
Title
Changes in the functional brain network connectivity
Description
Using functional Magnetic Resonance Imaging (fMRI) to assess the connectivity of the brain functional networks. fMRI is based on the principles of magnetic resonance and measures changes in blood oxygenation levels to reflect the activity of brain regions. Based on fMRI, the changes in connectivity of the brain functional networks are compared between 6 months after treatment and the baseline level.
Time Frame
Month 6
Title
Changes in the resting state brain network connectivity
Description
Using resting state functional Magnetic Resonance Imaging (rs-fMRI) to assess the connectivity of the brain resting-state network. Rs-fMRI examines the changes in blood oxygenation levels in different regions during rest, revealing the state of the resting-state neural networks. Based on rs-fMRI, the changes in connectivity of brain resting-state network are compared between 6 months after treatment and the baseline level.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Cao, M.D.
Phone
+86(010)59976510
Ext
100070
Email
caoyong@bjtth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Shaozhi Zhao, M.D.
Phone
+86 18801217693
Ext
100070
Email
sdsgzsz@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Cao, M.D.
Organizational Affiliation
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Cao, M.D.
Phone
+86(010)59976510
Ext
100070
Email
caoyong@bjtth.org
First Name & Middle Initial & Last Name & Degree
Shaozhi Zhao, M.D.
Phone
18801217693
Ext
100070
Email
sdsgzsz@163.com
First Name & Middle Initial & Last Name & Degree
Yong Cao, M.D.
Facility Name
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianwei Zeng, M.D.
Phone
+86 15810000385
Email
zengxwei@163.com
Facility Name
Shenzhen Qianhai Shekou Free Trade Zone Hospital
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiwei Wang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety Study: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH).

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