NCT05920473

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-06-27
• Last updated: 2023-06-27

Locations

3 sites across 1 country: China