Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Focused Ultrasound Stimulation.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound (fUS) Over the Motor Cortex
Overview
Through the BrainBox Initiative, investigators propose to study the effects of motor tFUS on Motor Evoked Potentials (MEPs) and GABA and Glutamate Concentrations in the Brain.
Detailed description
tFUS is an emerging neuromodulatory tool that uses pulses of low-intensity acoustic waves to stimulate deep brain structures such as the thalamus. tFUS has recently been used to probe deep brain structures in unresponsive wakefulness, pain, anxiety, and other neuropsychiatric conditions. However, tFUS is restricted mainly by use in the MR scanner environment, thus limiting session numbers by scan cost and participant comfort. Furthermore, with few human studies to date, the parameter space and mechanisms of action warrant further elucidation. Using novel focused ultrasound methods, investigators can stimulate at a minimum penetration distance of 20mm, uniquely enabling the study of the neuromodulatory effects of tFUS on cortical tissue. Specifically, investigators propose to study the effects of motor tFUS on motor-evoked potentials (MEPs) and GABA concentration. The proposed research is critical for understanding tFUS and advancing its therapeutic potential for future clinical trials.
Interventions
- Device Focused Ultrasound Stimulation
This aim will test whether motor tFUS parameters thought to be excitatory (50% duty cycle) vs. inhibitory (5% duty cycle) elicit their predicted effects on MEPs before and after each of three stimulation blocks, using 50 MEPs at each time point.
Primary outcome measures
- Motor Evoked Potential Amplitude [Time frame: Immediate Post-Stimulation]
Eligibility criteria
Inclusion criteria
- Male or female
- Age 18-55
- Endorse good health with no history of mental or physical illness or implanted metal
- English as a primary language
- Capacity to consent
- Negative urine pregnancy test if a female of childbearing potential
- Willingness to adhere to the tFUS and MRI study schedule
Exclusion criteria
- Any psychotropic medication is taken within 5 half-lives of procedure time
- Any head trauma resulting in loss of consciousness
- Personal or family history of neurological illness or injury
- Alcohol or substance abuse or dependence (other than tobacco) in the past week
- Diagnosis or current treatment (pharmacological or otherwise) of any psychiatric condition
- Pregnancy
- Personal or family history of seizures or epilepsy
- Claustrophobia or inability to stay still in the MR scanner environment
- Any metal in the body
- Other contraindications to electrical or electromagnetic stimulation
- Hair in dreadlocks, braids, or weave
- Diagnosis of COVID-19 in the past 14 days
- Inability to adhere to the treatment schedule.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT05792020 · Pro00124327