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

June 17, 2023 updated by: Dr. Yong Cao, Beijing Tiantan Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yong Cao, M.D.
  • Phone Number: 100070 +86(010)59976510
  • Email: caoyong@bjtth.org

Study Contact Backup

  • Name: Shaozhi Zhao, M.D.
  • Phone Number: 100070 +86 18801217693
  • Email: sdsgzsz@163.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
        • Contact:
      • Shenzhen, China
        • Recruiting
        • Shenzhen Qianhai Shekou Free Trade Zone Hospital
        • Contact:
          • Zhiwei Wang, M.D.
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Principal Investigator:
          • Yong Cao, M.D.
        • Contact:
        • Contact:
          • Shaozhi Zhao, M.D.
          • Phone Number: 100070 18801217693
          • Email: sdsgzsz@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants between the ages of 45 and 65 years old.
  2. More than 1 month and less than 3 months after ICH
  3. With severe and moderately severe motor functional impairment, indicated by a Functional Motor Assessment (FMA) score ranging from 0 to 55.
  4. Unilateral basal ganglia hemorrhage with a hematoma volume of 30-60ml, measured using the ABC2 method based on preoperative CT scans.
  5. 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.
  6. 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%.
  7. Signed the informed consent.

Exclusion Criteria:

  1. With a history of epilepsy.
  2. With movement disorders resulting from causes other than basal ganglia hemorrhage.
  3. With severe general impairment or coexisting medical conditions.
  4. With emotional issues or cognitive impairments, as indicated by a Mini-Mental State Examination (MMSE) score below 21.
  5. With any contraindications to transcranial magnetic stimulation (TMS), such as having metal implants in the brain or using a pacemaker.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS intervention group
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.
Device: rTMS with Magstim Rapid 2 magnetic stimulation device
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 Comparator: Sham group
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.
Device: sham control with Magstim Rapid 2 magnetic stimulation device
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer Assessment (FMA)
Time Frame: Day 1, Month 1, Month 3
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.
Day 1, Month 1, Month 3
Fugl-Meyer Assessment (FMA) Response
Time Frame: baseline, Day 1, Month 1, Month 3, Month 6
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.
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
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.
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
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.
Day 1, Month 1, Month 3, Month 6
Change in Barthel Index (BI) score
Time Frame: Day 1, Month 1, Month 3, Month 6
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.
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
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.
Day 1, Month 1, Month 3, Month 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the structural brain network connectivity
Time Frame: Month 6
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.
Month 6
Changes in the functional brain network connectivity
Time Frame: Month 6
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.
Month 6
Changes in the resting state brain network connectivity
Time Frame: Month 6
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.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
Shenzhen Qianhai Shekou Free Trade Zone Hospital

Investigators

  • Principal Investigator: Yong Cao, M.D., Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 17, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICH-rTMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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