A Novel Method of Non-Invasive Brain Stimulation (Kilohertz Transcranial Magnetic Perturbation) to Enhance Motor Function in Chronic Stroke Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Magnetic Tides
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Fugl- Meyer Assessment (Upper Extremity)
- Status
- Enrolling by Invitation
- Last Updated
- 11 months ago
Overview
Brief Summary
Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke.
Detailed Description
The goal of this clinical trial is to test and validate a novel first-in-class non-invasive approach to enhance motor function in chronic stroke patients. The kilohertz Transcranial Magnetic Perturbation (kTMP) device allows the investigators to target frequency-specific neural activity non-invasively - with no patient discomfort - at and beyond stimulation intensities associated with enhanced recovery from stroke (up to 8 V/m), something that is not possible to achieve with existing NIBS methods. The trial aims to evaluate the preliminary efficacy of kTMP in improving upper limb motor performance in patients suffering from chronic stroke. This clinical trial aims to target the perilesional motor cortex to assess both immediate and long-term improvement of motor performance, and corresponding physiological changes induced by kTMP stimulation.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Fugl- Meyer Assessment (Upper Extremity)
Time Frame: 10 months
A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment. It is graded from 0 (hemiplegia) to 66 for the Upper extremity. Higher scores signifies better motor control, and hence a better outcome.
Secondary Outcomes
- Grasp to Lift Time(10 months)
- Range of Joint Motion (ROM)(10 months)
- Action Research Arm Test (ARAT)(10 months)
- Modified Ashworth Scale (MAS)(10 months)
- Trial to Trial Variability (T2TV)(10 months)
- Transport Time(10 months)