Characterizing the Scalp Tolerability of TMS

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06354686
• Other study ID #: STUDY00004245
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Florida State University
• Contact: Isabelle Taylor, MA
• Phone: 8506458882
• Email: imtaylor[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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