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

Not Applicable

Recruiting

• Conditions: Intracerebral Hemorrhage

• Registration Number: NCT05920473
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-17
• Last Update Submitted: 2023-06-17
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Study Start: 2023-07-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Assessment (FMA)	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.

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (FMA) Response	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.
Change in Fugl-Meyer Assessment, Upper Limb (FMA-UL)	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.
Change in Fugl-Meyer Assessment, Lower Limb (FMA-LL)	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.
Change in NIH stroke scale (NIHSS) score	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.
Change in Barthel Index (BI) score	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.
Change in Fugl-Meyer Assessment (FMA)	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.

Trial Locations

Locations (3)

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, China