- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03130647
The Effects of Transcranial Focused Ultrasound on Human Motor Learning
September 8, 2017 updated by: University of Minnesota
Transcranial focused ultrasound (tFUS) is a form of neuromodulation that uses a single element transducer to produce highly focused low-intensity acoustic energy that can be used to affect cortical excitability in humans.
Study Overview
Detailed Description
Here the investigator plan to investigate the effect of tFUS on motor behavior.
M1 has been chosen for two fundamental reasons for this study: 1) The use of muscle contraction to generate a detectable evoked potential signal allows for targeting of a precise area within M1 with tFUS, and 2) It is known that M1 is involved in fast learning of sequential motor tasks By targeting M1 with tFUS in neurologically healthy volunteers, we can study the effects of tFUS on motor learning measures (e.g., reaction time, accuracy) while a subject is performing a finger tapping motor learning task.
If ultrasound is proven efficacious for stimulating the motor cortex, non-surgical ultrasound could potentially replace costly and risky surgery for the treatment of brain disorders as is common with deep brain stimulation for essential tremor or Parkinson's disease.
There is currently no way to affect brain tissue deep into the cortex without surgery, genetic alteration or viral vectors (the latter two are not approved for human use).
This technology is non-surgical and as invasive as any diagnostic ultrasound exam.
With success, transcranial focused ultrasound could become useful world-wide as a cheap, portable and effective tool for human brain mapping efforts as well as for the diagnosis and potential treatment of a broad range of psychiatric and neurological disorders.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 to 65 years of age Provide written informed consent
Exclusion Criteria:
- Evidence of a current significant medical illness or psychiatric or central or peripheral neurologic disorder 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) Taking any medications that may decrease the threshold for seizure Pregnancy 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 Left handedness. Failure to follow laboratory or study procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Focused ultrasound
Repeated measures sham control
|
Focused ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction Time
Time Frame: 4 months
|
Reaction time to visual stimulus response task
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 15, 2017
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
March 16, 2017
First Submitted That Met QC Criteria
April 24, 2017
First Posted (Actual)
April 26, 2017
Study Record Updates
Last Update Posted (Actual)
September 11, 2017
Last Update Submitted That Met QC Criteria
September 8, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- M1 ultrasound
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No sharing plan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Focused ultrasound
-
University of California, Los AngelesNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Deep Brain Stimulation | Amnestic Mild Cognitive Disorder | Mild Alzheimer's DiseaseUnited States
-
Shufang ChangRecruitingCervical Intraepithelial NeoplasiaChina
-
Virginia Polytechnic Institute and State UniversitySalem VA Medical Center; Washington DC VA Medical CenterNot yet recruitingChronic Pain | Opioid Use Disorder | Anxiety DisorderUnited States
-
Virginia Polytechnic Institute and State UniversityEnrolling by invitation
-
Marc Dall'Era, MDNational Cancer Institute (NCI)RecruitingLocalized Prostate Carcinoma | Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8United States
-
Chongqing Medical UniversityRecruitingThe Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral NeuropathyPainful Diabetic NeuropathyChina
-
Philips HealthcareCompletedSecondary Malignant Neoplasm of BoneFrance
-
University of California, San FranciscoCompletedUterine FibroidsUnited States
-
Neurological Associates of West Los AngelesRecruitingParkinson Disease | Essential Tremor | TremorUnited States
-
Brigham and Women's HospitalRecruitingDrug Resistant EpilepsyUnited States