Characterizing the Scalp Tolerability of TMS

Characterizing the Scalp Tolerability of Transcranial Magnetic Stimulation by Location and Stimulation Parameters

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: TMS Tolerability

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm; This will be a single arm study with measurements of scalp location and TMS stimulation parameters.

Device: TMS 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Threshold	Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which a tactile sensation was first detected during the study session.	During one study session lasting approximately 3 hours.
Annoyance Threshold	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.	During one study session lasting approximately 3 hours.
Tolerability Threshold	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.	During one study session lasting approximately 3 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of TMS (Knee Location)	Evaluation of the knee as a surrogate location to safely trial tolerability of TMS parameters. Qualitative descriptors (McGill Pain Questionnaire) will be selected by participants from a list of words and used to describe the quality of the TMS pulse (e.g. flickering, pricking, sharp, pinching, tugging, tingling, etc.).	3-36 months

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Actual): February 20, 2026
• Study Completion (Actual): February 20, 2026

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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