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

Intracerebral Hemorrhage Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920473
• Other study ID #: ICH-rTMS
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Beijing Tiantan Hospital
• Contact: Yong Cao, M.D.
• Phone: +86(010)59976510
• Email: caoyong[@]bjtth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study aims to assess the effectiveness and safety of rTMS in the treatment of movement disorders in patients with ICH.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Intracranial Hemorrhages
• Movement Disorders

Intervention

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 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids	Beijing
China	Shenzhen Qianhai Shekou Free Trade Zone Hospital	Shenzhen

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Qianhai Shekou Free Trade Zone Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in the structural brain network connectivity	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
Other	Changes in the functional brain network connectivity	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
Other	Changes in the resting state brain network connectivity	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
Primary	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.	Month 6
Secondary	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.	Day 1, Month 1, Month 3
Secondary	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.	baseline, Day 1, Month 1, Month 3, Month 6
Secondary	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.	Day 1, Month 1, Month 3, Month 6
Secondary	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.	Day 1, Month 1, Month 3, Month 6
Secondary	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.	Day 1, Month 1, Month 3, Month 6
Secondary	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.	Day 1, Month 1, Month 3, Month 6