Neurologic Symptoms
Conditions
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.
Interventions
DEVICErTMS
repetitive Transcranial Magnetic Stimultion
Sponsors
Neuronetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in multiple symptoms after rTMS treatment. | 4 weeks | Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to end of acute. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durability of changes in symptoms | 16 weeks | Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to final follow-up visit. |
Countries
United States
Contacts
STUDY_DIRECTORSteve Erickson
Neuronetics
Outcome results
None listed