Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation (SET)

A Prospective Study to Evaluate Symptoms Following Repetitive Transcranial Magnetic Stimulation (rTMS)

A prospective study to evaluate symptoms following repetitive transcranial Magnetic stimulation.

Study Overview

• Status: Active, not recruiting
• Conditions: Neurologic Symptoms
• Intervention / Treatment: Device: rTMS

Detailed Description

Open-label, multicenter, prospective pilot study conducted in an adult population receiving rTMS treatment.

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

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Skin and Laser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults, 22 to 70 years of age
2. Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
3. Score > or = 8 on ISI scale
4. If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.
5. If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
6. Subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc.

Exclusion Criteria:

1. Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
2. History of head trauma associated with loss of consciousness or diagnosed as concussion.
3. History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
4. Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
5. Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
6. Has medication infusion device.
7. Subjects with any prior TMS or MRI complications, or any other issues/circumstance which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation.
8. PHQ-9 total score > or = 10 or QIDS total score > or = 11.
9. Drug abuse or dependence of the illicit substance. (Abuse or Dependence, as defined by DSM-V-TR)
10. Current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure)
11. Other known disorder (e.g., narcolepsy, a breathing-related sleep disorder like Obstructive Sleep Apnea, a circadian rhythm sleep-wake disorder, a parasomnia) as defined by DSM-V-TR.
12. Has a clinically significant abnormality on the screening examination.
13. Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Open Label; Single Group	Device: rTMS; repetitive Transcranial Magnetic Stimultion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in multiple symptoms after rTMS treatment.	Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to end of acute.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability of changes in symptoms	Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to final follow-up visit.	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome	Treatment related Adverse Events	16 weeks

Collaborators and Investigators

• Sponsor: Neuronetics
• Investigators: Study Director: Steve Erickson, Neuronetics

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): April 29, 2025
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations
• Other Study ID Numbers: 44-50019-000

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