Development of LIFU for Clinical Purposes
Conditions
Keywords
low-intensity focused ultrasound, transcranial magnetic stimulation
Brief summary
This project examines the effects of different brain stimulation settings on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, an fMRI and CT. These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions on the hand.
Interventions
LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.
Sponsors
Virginia Polytechnic Institute and State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Multi-visit study, testing various LIFU parameters per session
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Above criteria and must understand and speak English.
Exclusion criteria
* Contraindications to MRI, CT, or TMS 1. Claustrophobia 2. Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants. 3. Pregnancy 4. Active medical disorder or treatment with potential CNS effects 5. History of neurologic disorder 6. History of head injury resulting in loss of consciousness for \>10 minutes 7. History of alcohol or drug dependence 8. Failure to provide a social security number or tax ID number. This is required for tax purposes or payment cannot be processed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waveforms | Outcome measured throughout study participation - an average of 4 weeks per participant. | Changes in waveform peak will be observed per each variable application of LIFU |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parameter Trials Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG.
Low-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | MEP value too low | 2 |
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | Parameter Trials |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 29 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Waveforms
Changes in waveform peak will be observed per each variable application of LIFU
Time frame: Outcome measured throughout study participation - an average of 4 weeks per participant.
Population: One participant data set had artifacts that could not be removed while leaving usable MEP data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parameter Trials | Waveforms | Parameter 1 (6W/cm2-1%DC-100msec) | 1.06 percentage of baseline MEP mV | Standard Deviation 0.12 |
| Parameter Trials | Waveforms | Parameter 2 (6W/cm2-10%DC-100msec) | 1.10 percentage of baseline MEP mV | Standard Deviation 0.12 |
| Parameter Trials | Waveforms | Parameter 3 (6W/cm2-30%DC-100msec) | 0.97 percentage of baseline MEP mV | Standard Deviation 0.1 |
| Parameter Trials | Waveforms | Parameter 4 (6W/cm2-50%DC-100msec) | 0.99 percentage of baseline MEP mV | Standard Deviation 0.1 |
| Parameter Trials | Waveforms | Parameter 5 (6W/cm2-70%DC-100msec) | 1.03 percentage of baseline MEP mV | Standard Deviation 0.13 |
| Parameter Trials | Waveforms | Parameter 6 (6W/cm2-1%DC-500msec) | 0.80 percentage of baseline MEP mV | Standard Deviation 0.1 |
| Parameter Trials | Waveforms | Parameter 7 (6W/cm2-10%DC-500msec) | 0.84 percentage of baseline MEP mV | Standard Deviation 0.1 |
| Parameter Trials | Waveforms | Parameter 8 (6W/cm2-30%DC-500msec) | 0.70 percentage of baseline MEP mV | Standard Deviation 0.08 |
| Parameter Trials | Waveforms | Parameter 9 (6W/cm2-50%DC-500msec) | 0.81 percentage of baseline MEP mV | Standard Deviation 0.11 |
| Parameter Trials | Waveforms | Parameter 10 (6W/cm2-70%DC-500msec) | 0.75 percentage of baseline MEP mV | Standard Deviation 0.08 |
| Parameter Trials | Waveforms | Parameter 11 (24W/cm2-1%DC-100msec) | 0.86 percentage of baseline MEP mV | Standard Deviation 0.09 |
| Parameter Trials | Waveforms | Parameter 12 (24W/cm2-10%DC-100msec) | 0.93 percentage of baseline MEP mV | Standard Deviation 0.11 |
| Parameter Trials | Waveforms | Parameter 13 (24W/cm2-30%DC-100msec) | 1.01 percentage of baseline MEP mV | Standard Deviation 0.12 |
| Parameter Trials | Waveforms | Parameter 14 (24W/cm2-50%DC-100msec) | 0.91 percentage of baseline MEP mV | Standard Deviation 0.12 |
| Parameter Trials | Waveforms | Parameter 15 (24W/cm2-70%DC-100msec) | 0.91 percentage of baseline MEP mV | Standard Deviation 0.09 |
| Parameter Trials | Waveforms | Parameter 16 (24W/cm2-1%DC-500msec) | 0.75 percentage of baseline MEP mV | Standard Deviation 0.07 |
| Parameter Trials | Waveforms | Parameter 17 (24W/cm2-10%DC-500msec) | 0.79 percentage of baseline MEP mV | Standard Deviation 0.1 |
| Parameter Trials | Waveforms | Parameter 18 (24W/cm2-30%DC-500msec) | 0.84 percentage of baseline MEP mV | Standard Deviation 0.1 |
| Parameter Trials | Waveforms | Parameter 19 (24W/cm2-50%DC-500msec) | 0.93 percentage of baseline MEP mV | Standard Deviation 0.13 |
| Parameter Trials | Waveforms | Parameter 20 (24W/cm2-70%DC-500msec) | 0.84 percentage of baseline MEP mV | Standard Deviation 0.09 |
| Parameter Trials | Waveforms | Parameter 21 (continuous- 6W/cm2-35000 cycles) | 0.84 percentage of baseline MEP mV | Standard Deviation 0.11 |
| Parameter Trials | Waveforms | Parameter 22 (continuous- 24W/cm2-35000 cycles) | 1.05 percentage of baseline MEP mV | Standard Deviation 0.13 |
| Parameter Trials | Waveforms | Parameter 23 (continuous- 6W/cm2-75000 cycles) | 1.10 percentage of baseline MEP mV | Standard Deviation 0.13 |
| Parameter Trials | Waveforms | Parameter 24 (continuous- 24W/cm2-75000 cycles) | 0.99 percentage of baseline MEP mV | Standard Deviation 0.1 |