Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation

NCT06429748 | Active Not Recruiting FDA Device

• 1 other identifier: 44-50019-000
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurologic Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Durability of changes in symptoms

  16 weeks

Other Outcomes (1)

• Safety Outcome

  16 weeks

Study Arms (1)

Open Label

EXPERIMENTAL

Single Group

Device: rTMS

Interventions

rTMS DEVICE

repetitive Transcranial Magnetic Stimultion

Open Label

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, 22 to 70 years of age
• Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
• Score \> or = 8 on ISI scale
• 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.
• If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
• Subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc.

You may not qualify if:

• Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
• History of head trauma associated with loss of consciousness or diagnosed as concussion.
• History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
• Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
• Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
• Has medication infusion device.
• 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.
• PHQ-9 total score \> or = 10 or QIDS total score \> or = 11.
• Drug abuse or dependence of the illicit substance. (Abuse or Dependence, as defined by DSM-V-TR)
• Current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure)
• 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.
• Has a clinically significant abnormality on the screening examination.
• Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.

Sponsors & Collaborators

• Neuronetics: lead

Study Sites (1)

Charlotte Skin and Laser

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steve Erickson

  Neuronetics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: May 15, 2024
• Primary Completion: April 29, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (1)