Clinical trial NCT05920473: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage
Movement Disorders
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
name: Shenzhen Qianhai Shekou Free Trade Zone Hospital
First posted: 2023-06-27
Enrollment: 130
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Fugl-Meyer Assessment (FMA)
timeFrame: Month 6
Secondary outcomes:
measure: Change in Fugl-Meyer Assessment (FMA)
timeFrame: Day 1, Month 1, Month 3
measure: Fugl-Meyer Assessment (FMA) Response
timeFrame: baseline, Day 1, Month 1, Month 3, Month 6
measure: Change in Fugl-Meyer Assessment, Upper Limb (FMA-UL)
timeFrame: Day 1, Month 1, Month 3, Month 6
measure: Change in Fugl-Meyer Assessment, Lower Limb (FMA-LL)
timeFrame: Day 1, Month 1, Month 3, Month 6
measure: Change in Barthel Index (BI) score
timeFrame: Day 1, Month 1, Month 3, Month 6
measure: Change in NIH stroke scale (NIHSS) score
timeFrame: Day 1, Month 1, Month 3, Month 6
Other outcomes:
measure: Changes in the structural brain network connectivity
timeFrame: Month 6
measure: Changes in the functional brain network connectivity
timeFrame: Month 6
measure: Changes in the resting state brain network connectivity
timeFrame: Month 6
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
city: Shenzhen
country: China
facility: Shenzhen Qianhai Shekou Free Trade Zone Hospital
Study officials:
affiliation: Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
name: Yong Cao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: