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

Magnetic Tides7 enrolled

Overview

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 feasibility and efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke.

The goal of this pilot clinical trial is to test the feasibility of 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 also aims to assess the preliminary effects of kTMP on upper limb motor performance in individuals with chronic stroke. kTMP stimulation is targeted to the motor hotspot for eliciting motor evoked potentials (MEPs) within motor cortex to evaluate both immediate and longer-term changes in motor performance.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

kTMPDEVICE

A new non-invasive brain stimulation tool

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Age 18-80 years with stable upper limb motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to recruitment 2. Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50 3. Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP+), a proxy of residual corticospinal function. Exclusion criteria: 1. Participants with cognitive impairment (MoCA \< 20), language impairment that interferes with their ability to adhere to the protocol or to provide informed consent. 2. Individuals who are pregnant, have uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year, or major depression. 3. Contraindications related to non-invasive brain stimulation

Locations (1)

Magnetic Tides, Inc.

Berkeley, California, United States

Outcomes

Primary Outcomes

Fugl- Meyer Assessment (Upper Extremity)

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.

Time frame: 8 weeks

Secondary Outcomes

Movement smoothness of Reach-to-Grasp

Movement smoothness of the reach phase will be quantified using three-dimensional hand kinematics recorded via an electromagnetic motion capture system. Spectral Arc Length (SPARC): A frequency-domain measure of movement smoothness (Balasubramanian et al., 2015, Journal of NeuroEngineering and Rehabilitation). More negative values indicate less smooth, more fragmented movement.

Time frame: 8 weeks

Action Research Arm Test (ARAT)

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.

Time frame: 8 weeks

Trial to Trial Variability (T2TV)

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.

Time frame: 8 weeks

Range of Joint Motion (ROM)

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

Time frame: 8 weeks

Grasp to Lift Time

Data from ClinicalTrials.gov

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