Healthy
Conditions
Brief summary
The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters.
Interventions
DEVICETMS Tolerability
The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the feasibility of the knee as a surrogate location to safely trial TMS parameters.
Sponsors
Florida State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults ages 18 years and older. 2. Capable to give informed written consent, ability to understand study procedures, and ability to comply with procedures for the entire length of the study. 3. Individuals with and without prior exposure to TMS are eligible (including individuals who have received TMS to treat depression).
Exclusion criteria
1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.). 2. Contraindication for scalp sensitivity and tolerability testing (e.g., sunburn, active headache, history of frequent and severe headaches). 3. Contraindication for knee sensitivity and tolerability testing (e.g., current knee injury or ongoing complications from prior history of knee surgery), unless knee testing skipped at the investigators' discretion. 4. Contraindication for participants with metal in both knees, unless knee testing skipped at the investigators' discretion. 5. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment 6. Dementia or other cognitive disorder making unable to engage in study. 7. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness. 8. Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.). 9. Any medication or substance use that significantly impacts sensory and tolerability measures based on the investigators' review of dosing and effect (e.g., topical anesthetics, botulinum toxin injections, ketamine, NSAIDS, opioids, anticonvulsants used in pain management, etc.). 10. Current, planned, or suspected pregnancy. 11. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.). 12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation). The investigators will exclude the following individuals: * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensory Threshold | During one study session lasting approximately 3 hours. | Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which a tactile sensation was first detected during the study session. |
| Annoyance Threshold | During one study session lasting approximately 3 hours. | Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which the tactile sensation was first perceived as annoying during the study session. |
| Tolerability Threshold | During one study session lasting approximately 3 hours. | Maximum stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), tolerated before the stimulation was rated as troublesome or miserable during the study session. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Tallahassee, FL, area and were able to travel to the laboratory. Recruitment methods included flyer distribution, social media, and the FSU Participate in Research webpage.
Pre-assignment details
Of the 20 participants who consented, 18 completed the study procedures and were included in the analysis. One participant discontinued because of scheduling conflicts, and one participant was unable to complete the procedures because of discomfort.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 21.6 |
| Generalized Anxiety Disorder-7 Score | 2.8 points STANDARD_DEVIATION 4.6 |
| Patient Health Questionnaire-9 | 2.8 points STANDARD_DEVIATION 4.4 |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed