Developing and Optimizing Transcranial Magnetic Stimulation for Motor Rehabilitation

• Sponsor: Elisa Kallioniemi (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05861284
• Collaborator: (none)
• Enrollment: 45
• Arms: 3
• Anticipated Duration (Months): 36

Study Details

Study Description

Brief Summary

This study aims to evaluate three different transcranial magnetic stimulation protocols and their impact on motor system neurophysiology and skill learning.

Condition or Disease	Intervention/Treatment	Phase
Motor Cortex; Motor Skills	Device: Transcranial Magnetic Stimulation (TMS)	N/A

Detailed Description

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method that induces long-term changes in connections between neuronal networks. This and the ability to activate the whole motor system allows the use of TMS to facilitate motor recovery. The motor system has different excitatory states associated with ongoing mu oscillation. Here, the investigators will monitor brain mu oscillations in real-time non-invasively using electroencephalography and modulate the function of the motor system. The investigators will test the impact of three different TMS protocols on motor system neurophysiology and skill learning. These data will provide novel understanding needed to improve TMS approaches for individuals requiring motor rehabilitation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Developing and Optimizing Transcranial Magnetic Stimulation for Motor Rehabilitation
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2025
• Anticipated Study Completion Date: Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single-pulse TMS over the primary motor cortex We will administer single-pulse TMS to the primary motor cortex while measuring motor responses and just before a skill-learning task.	Device: Transcranial Magnetic Stimulation (TMS); Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method that can induce long-term changes in connections between neuronal networks.
Experimental: Paired-pulse TMS over the primary motor cortex We will administer paired-pulse TMS to the primary motor cortex while measuring motor responses and just before a skill-learning task.	Device: Transcranial Magnetic Stimulation (TMS); Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method that can induce long-term changes in connections between neuronal networks.
Sham Comparator: Sham TMS over the primary motor cortex We will administer sham TMS to the primary motor cortex while measuring motor responses and before a skill-learning task.	Device: Transcranial Magnetic Stimulation (TMS); Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method that can induce long-term changes in connections between neuronal networks.

Outcome Measures

Primary Outcome Measures

1. Effect of TMS on motor evoked potentials [Up to 1 second after TMS]

   Amplitude of the motor evoked potentials in millivolts.

2. Skill learning accuracy [Up to 12 minutes]

   Skill learning accuracy as the total number of correct responses.

3. Skill learning speed [Up to 12 minutes]

   Skill learning speed in seconds.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18-40 years old

• Able to read, understand, and sign the informed consent in English

• Right-handed

Exclusion Criteria:

• A sensory or physical impairment

• History of epilepsy or seizures in the family

• Non-removable metal or electronics (e.g., a cochlear implant, cardiac pacemaker, or implanted electronic devices) in your head or body

• A head injury with loss of consciousness

• Diagnosis of psychiatric or neurological disorder

• Skin defects or active infections on the scalp or hands

• Pregnancy or breastfeeding

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Elisa Kallioniemi

Investigators

• Principal Investigator: Elisa Kallioniemi, Ph.D., New Jersey Institute of Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elisa Kallioniemi, Assistant Professor, New Jersey Institute of Technology
• ClinicalTrials.gov Identifier: NCT05861284
• Other Study ID Numbers: IRB_2303032088
• First Posted: May 16, 2023
• Last Update Posted: May 17, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elisa Kallioniemi, Assistant Professor, New Jersey Institute of Technology: TMS; Motor system; Healthy

Study Results

No Results Posted as of May 17, 2023