A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients

Not Applicable

• Conditions: Stroke
• Interventions: Device: kTMP; Device: Sham kTMP

• Registration Number: NCT06317194
• Lead Sponsor: Magnetic Tides

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.

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Study Start: 2025-09-15
• Primary Completion: 2027-06-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active kTMP	kTMP	Participants received 2-8 V/m of active stimulation
Sham kTMP	Sham kTMP	Participants received 0.01 V/m of sham stimulation

Primary Outcome Measures

Name	Time	Method
Fugl- Meyer Assessment (Upper Extremity)	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 Outcome Measures

Name	Time	Method
Grasp to Lift Time	10 months	Calculated for each of three epochs, pre, during and post
Range of Joint Motion (ROM)	10 months	defined as the standard deviation of the joint angle time series for a given trial. The median ROM will be calculated for eleven degrees of freedom and then averaged. If there are joints which appear to be compensatory, they will be removed from the analysis
Action Research Arm Test (ARAT)	10 months	A standardized assessment of functional hand motor performance measured by four basic movements used in everyday life (gross arm movement, grasp, grip and pinch). The scores range from 0 to 57. Higher score means a better arm motor status.
Modified Ashworth Scale (MAS)	10 months	Used to measure spasticity in wrist and hand flexors and extensors. It assigns a grade of spasticity from 0-4. Lower scores represent normal muscle tone and higher scores represent spasticity. Hence lower scores are associated with better outcomes.
Trial to Trial Variability (T2TV)	10 months	Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries. The median T2TV will be calculated for eleven degrees of freedom.
Transport Time	10 months	Calculated for each of three epochs, pre, during and post

Trial Locations

Locations (1)

Magnetic Tides; 🇺🇸 El Cerrito, California, United States