Characterizing the Scalp Tolerability of TMS

NCT06354686 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY00004245
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Tolerability of TMS - Scalp Location

  Characterization of the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) using the McGill Pain Questionnaire and;

  3-36 months

• Tolerability of TMS - Stimulation parameters (single pulse, 10 Hz, theta burst).

  Characterization of the tolerability of TMS by stimulation parameters (single pulse, 10 Hz, theta burst) using the McGill Pain Questionnaire.

  3-36 months

Secondary Outcomes (1)

• Tolerability of TMS (Knee Location)

  3-36 months

Study Arms (1)

Single Arm

EXPERIMENTAL

This will be a single arm study with measurements of scalp location and TMS stimulation parameters.

Device: TMS Tolerability

Interventions

TMS Tolerability DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18 years and older.
• Capable to give informed written consent, ability to understand study procedures, and ability to comply with procedures for the entire length of the study.
• Individuals with and without prior exposure to TMS are eligible (including individuals who have received TMS to treat depression).

You may not qualify if:

• Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
• Contraindication for scalp sensitivity and tolerability testing (e.g., sunburn, active headache, history of frequent and severe headaches).
• 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.
• Contraindication for participants with metal in both knees, unless knee testing skipped at the investigators' discretion.
• Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
• Dementia or other cognitive disorder making unable to engage in study.
• Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
• Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.).
• 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.).
• Current, planned, or suspected pregnancy.
• 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.).
• 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)

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Faculty

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: April 9, 2024
• Study Start: February 12, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)