NeoSync TMS Treatment for Bipolar I Depression
Condition: Major Depressive Episode; Bipolar Depression; Bipolar Disorder; Mood Disorders
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder; Mood Disorders; Depressive Disorder, Major
Intervention: NEST (NeoSync EEG Synchronized TMS)
Intervention description: The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Bipolar Depression.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label, unblinded treatment series, all participants receive active treatment with the investigational device (NeoSync sTMS), as adjunct to ongoing stable pharmacotherapy
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: sTMS; NEST; NeoSync; synchronous; non-invasive neuromodulation; TMS; transcranial magnetic stimulation; EEG; bipolar; depression

Summary:

      This study is designed to evaluate the safety and preliminary efficacy of synchronized
      transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST)
      in subjects with Bipolar Disorder type I in a Major Depressive Episode. This is an open label
      study in which subjects will receive treatment 5 days per week for 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria: Subjects must meet all of the following inclusion criteria to qualify
        for enrollment into the study:

          1. 18 - 70 years of age;

          2. DSM-5 primary diagnosis of Bipolar Disorder type 1 (with a documented past manic
             episode), currently in a Major Depressive Episode by diagnostic criteria elicited by
             structured clinical interview (SCID-5-RV);

          3. MADRS score ≥ 20;

          4. Duration of current episode >4 weeks

          5. YMRS score ≤ 12;

          6. baseline EEG of sufficient quality for quantitative analysis processing;

          7. willing and able to adhere to the intensive treatment schedule and all required study
             visits;

          8. currently on adequate dose of mood stabilizer with significant evidence base or FDA
             approval as antimanic or for maintenance therapy of bipolar disorder (e.g, valproic
             acid/divalproex, carbamazepine, lithium, aripiprazole, ziprasidone, risperidone,
             quetiapine, olanzapine, asenapine, haloperidol, chlorpromazine, paliperidone,
             cariprazine).

        Exclusion Criteria: Subjects will be excluded from study participation if one of the
        following exclusion criteria applies:

          1. unable or unwilling to give informed consent;

          2. diagnosed with current primary psychotic disorder (rather than BD);

          3. diagnosed with current mania or hypomanic mood episode;

          4. history of moderate to severe substance use disorder within the past 6 months (except
             nicotine and caffeine);

          5. currently being treated with a stimulant;

          6. clinically defined major neurological disorder; including, but not limited to, seizure
             disorder and history of loss of consciousness due to head injury for greater than 10
             minutes, or with documented evidence of brain injury;

          7. increased risk of seizure for any reason, including diagnosis of increased
             intracranial pressure, comorbid neurological disorder, use of certain medications,
             highly unstable use of alcohol or benzodiazepines;

          8. initiation of new antidepressant treatments (new medication, new device-based
             stimulation, or new psychotherapy) within 6 weeks prior to study baseline;

          9. active suicidal intent or plan as detected on screening assessments, or in the
             Investigator's opinion, is likely to attempt suicide within the next six months;

         10. presence of implanted cardiac pacemakers, implanted medication pumps, or intracardiac
             lines;

         11. intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants,
             stents, or electrodes) or any other metal object within or near the head (excluding
             the mouth), which cannot be safely removed;

         12. clinically significant unstable medical condition;

         13. if female: pregnant, not using medically acceptable means of birth control, or
             currently breastfeeding;

         14. other condition, which in the judgment of the Investigator could prevent the subject
             from completion of the study;

         15. for participants in the MRI study: ferromagnetic metal implant or other
             contraindication to imaging in a 3 Tesla MRI;

         16. past treatment with TMS therapy.