Indications & FDA Status
This page is intended to be educational. It summarizes what is known from published research and ongoing studies. It is not medical advice and does not make promises of benefit. Results vary.
FDA status: The EXOMIND/BTL TMS device is FDA-cleared for Major Depressive Disorder (MDD) only. All other conditions listed are investigational/off-label uses of this device.
What “off-label” means: a treatment approved for one indication is used in another condition based on available evidence and clinical judgment. Off-label use involves uncertainties; not all patients benefit.
How We Present Information
- We focus on facts and education (what studies suggest, where research is ongoing).
- We avoid absolute claims; we use conditional phrasing (e.g., “may help,” “has shown potential”).
- Where appropriate, we reference evidence and direct you to additional resources or our Medical Disclaimer.
FDA-Cleared
- Major Depressive Disorder (MDD)FDA
Investigational / Off-Label Indications
Mood disorders
- Generalized Anxiety Disorder (GAD)†
- Dysthymia (Persistent Depressive Disorder)†
- Postpartum depression†
- Premenstrual dysphoric disorder (PMDD)†
- Postmenopausal depression†
- Schizophrenia — negative symptoms†
- Bipolar II depression (with mood stabilization)†
Addictions & cognitive disorders
- Nicotine, alcohol, and drug addiction†
- Binge eating and food cravings†
- Anorexia†
- Gambling and technology addiction†
- Multiple sclerosis (MS)†
- Parkinson’s disease†
- Post-stroke recovery†
- Mild cognitive impairment (MCI)†
- Early-stage Alzheimer’s disease†
- Post-COVID “brain fog”†
- Traumatic brain injury (TBI)†
- “Chemo brain” (cancer-related cognitive impairment)†
- Age-related cognitive decline†
Sleep, fatigue & pain
- Insomnia†
- Circadian rhythm disturbance†
- Hypersomnia in depression†
- Chronic fatigue syndrome (ME/CFS)†
- Fibromyalgia†
- Chronic pain syndromes†
- Tension-type headaches†
- Neuropathic pain†
- IBS (mood-related symptom relief)†
Trauma & neurodevelopment
- Post-traumatic stress disorder (PTSD)†
- ADHD†
- Autism spectrum disorder (ASD)†
- Learning disabilities (cognitive processing)†
- Tourette’s†
Other off-label indications
- Obsessive–Compulsive Disorder (OCD)†
- Smoking cessation†
- Migraine†
Informed-Consent Process
- All patients receive a written informed-consent form that clearly distinguishes the FDA-cleared indication (MDD) from investigational/off-label uses.
- The consent covers known and unknown risks, alternatives (including no treatment), and the voluntary nature of participation.
- We discuss expectations in conditional terms (e.g., “may help,” “has shown potential in studies”).
Safety Program (Summary)
- Collaboration with psychiatry for diagnosis confirmation, management of high-risk patients, and referral of non-responders when appropriate.
- Standardized screening (e.g., seizure risk, implanted devices/contraindications) and written emergency procedures (including seizure response and suicidality escalation).
- Hearing protection and safety monitoring at every treatment session.
- Outcome tracking (e.g., PHQ-9/MADRS at baseline and follow-up) and documentation consistent with payer requirements.
Treatment Responses & Risks
Treatment responses vary. Some patients may not benefit, and this intervention carries inherent risks and uncertainties. Please speak with your physician for individualized assessment.
To learn whether an option may be appropriate for you, please schedule an educational consultation. This discussion is informational and does not obligate you to pursue treatment.
See our Medical Disclaimer for important information about risks, alternatives, and limitations of evidence.
Medical Disclaimer
The information on this site is for general educational purposes only and is not medical advice, diagnosis, or treatment. Reading this site does not create a doctor–patient relationship. Always consult a qualified healthcare professional for personal guidance. If this is an emergency, call 911. Mentions of medications, devices, or procedures are informational and not endorsements. Full medical disclaimer.
†Some listed indications involve investigational/off-label use. Learn more.