Clinical trial NCT06429748: Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation
Official title: A Prospective Study to Evaluate Symptoms Following Repetitive Transcranial Magnetic Stimulation (rTMS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neurologic Symptoms
Lead sponsor: Neuronetics
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in multiple symptoms after rTMS treatment.
timeFrame: 4 weeks
Secondary outcomes:
measure: Durability of changes in symptoms
timeFrame: 16 weeks
Other outcomes:
measure: Safety Outcome
timeFrame: 16 weeks
Locations:
city: Charlotte
country: United States
facility: Charlotte Skin and Laser
state: North Carolina
Study officials:
affiliation: Neuronetics
name: Steve Erickson
role: STUDY_DIRECTOR
References: