Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation

Neurologic Symptoms Clinical Trial

— SET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429748
• Other study ID #: 44-50019-000
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Neuronetics
• Contact: Neha Goyal
• Phone: 7635281599
• Email: neha.goyal[@]neurostar.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurologic Manifestations
• Neurologic Symptoms

Intervention

Device:
• rTMS
repetitive Transcranial Magnetic Stimultion

Locations

Country	Name	City	State
United States	Charlotte Skin and Laser	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Neuronetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcome	Treatment related Adverse Events	16 weeks
Primary	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	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