Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation

Launched by NEURONETICS · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how repetitive transcranial magnetic stimulation (TMS) can help with certain neurological symptoms. TMS is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain. The study aims to understand the effects of this treatment on patients' symptoms. They are currently recruiting adults aged 22 to 70 who have a score of 8 or higher on a specific sleep issues scale. Participants will need to provide written consent and commit to attending all study visits and assessments.

To be eligible, participants should not have a history of certain neurological conditions, head trauma, or specific medical devices in or near their head. They also need to be stable on any psychiatric or sleep medications for at least two weeks before joining the study. Those who participate can expect to undergo the TMS treatment and share their experiences and symptoms throughout the trial. This research could provide valuable insights into how TMS may improve neurological symptoms for many individuals.

Gender

ALL

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.

Trial Officials