Clinical trial NCT06317194: A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients
Official title: A Novel Method of Non-Invasive Brain Stimulation (Kilohertz Transcranial Magnetic Perturbation) to Enhance Motor Function in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Keywords: kTMP
Motor Rehabilitation
Ischemic Stroke
Hemorrhagic Stroke
Cerebrovascular disease
Cortical Excitability
Plasticity
Neuroscience
Stroke
Central Nervous System Disease
kilohertz Transcranial Magnetic Perturbation
Lead sponsor: Magnetic Tides
Sponsor class: INDUSTRY
Collaborators: name: University of California, Berkeley
First posted: 2024-03-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion criteria:

1. Age 18 or older 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 28-60
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

Primary outcomes:
measure: Fugl- Meyer Assessment (Upper Extremity)
timeFrame: 10 months
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 10 months
measure: Modified Ashworth Scale (MAS)
timeFrame: 10 months
measure: Trial to Trial Variability (T2TV)
timeFrame: 10 months
measure: Range of Joint Motion (ROM)
timeFrame: 10 months
measure: Grasp to Lift Time
timeFrame: 10 months
measure: Transport Time
timeFrame: 10 months
Other outcomes:
Locations:
city: El Cerrito
country: United States
facility: Magnetic Tides
state: California
Study officials:
References: