Viewing Study NCT05920473



Ignite Creation Date: 2024-05-06 @ 7:12 PM
Last Modification Date: 2024-10-26 @ 3:01 PM
Study NCT ID: NCT05920473
Status: RECRUITING
Last Update Posted: 2023-06-27
First Post: 2023-06-04

Brief Title: Efficacy and Safety Study Repetitive Transcranial Magnetic Stimulation rTMS for Treating Movement Disorders in Patients With Intracranial Hemorrhage ICH
Sponsor: Beijing Tiantan Hospital
Organization: Beijing Tiantan Hospital

Study Overview

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
Status: RECRUITING
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None