NeoSync TMS Treatment for Bipolar I Depression

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.