Ultrasound Effects on Human Motor Cortical Plasticity

NCT ID: NCT04168762

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2020-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to test the duration and effect of single element focused ultrasound to the primary motor cortex on healthy human participants with the use of transcranial focused ultrasound and transcranial magnetic stimulation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Previous research has shown ultrasound to inhibit motor cortical excitability though it is currently not known how long these effects last. This is an important consideration if ultrasound is to be translated and advanced to clinical or therapeutic uses as this study will help to determine suitable ultrasound durations for efficacious use. The investigators will test the duration of ultrasound neuromodulation using transcranial magnetic stimulation which will elicit a recordable and quantifiable metric of motor cortical excitability in the form of a motor evoked potential.

Participants will complete 3 study visits. During the first study visit, participants will complete Magnetic Resonance Imaging and Computed Tomography scans for TUMS localization in visits 2 and 3. Each participant will undergo motor cortex thresholding prior to their study TUMS stimulation procedure. Depending on randomization, subjects may receive one or two TUMS stimulation procedures at each session.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized into two groups. Group A will receive a two part Transcranial Ultrasound Magnetic Stimulation (TUMS) on two visits and Group B will receive a one part TUMS on two visits.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will be masks from the specific details of the type of TUMS stimulation they are receiving.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TUMS and Sham Group

During the subjects two visits they will receive a TUMS stimulation and a sham (placebo) stimulation at both visits.

Group Type EXPERIMENTAL

Transcranial Ultrasound Magnetic Stimulation

Intervention Type OTHER

Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).

TUMS or Sham Group

During the subjects first of two visits they will receive either a TUMS stimulation or a sham (placebo) stimulation and at the second visit they will receive the other.

Group Type EXPERIMENTAL

Transcranial Ultrasound Magnetic Stimulation

Intervention Type OTHER

Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial Ultrasound Magnetic Stimulation

Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy, adult subject
* 18-65 years of age
* Provided informed consent

Exclusion Criteria

* Presence of a significant medical, psychiatric, or neurologic illness
* History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services
* Personal or family history of seizure
* Any history of stroke/transient ischemic attack (TIA) or severe traumatic brain injury
* Taking any medications that may decrease the threshold for seizure
* Pregnancy (self-reported)
* Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully balanced by the PI
* Failure to follow laboratory or study procedures
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sarah Adams

Role: CONTACT

434-243-4319

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sarah Adams

Role: primary

434-243-4319

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20620

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Accelerating TMS for Cervical Dystonia
NCT06328114 ENROLLING_BY_INVITATION NA