NeoSync TMS Treatment for Bipolar I Depression

NCT02839798 | Terminated Phase 2 Results

• 1 other identifier: 1601-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Episode; Bipolar Depression; Bipolar Disorder; Mood Disorders

Keywords

sTMS; NEST; NeoSync; synchronous; non-invasive neuromodulation; TMS; transcranial magnetic stimulation; EEG; bipolar; depression

Outcome Measures

Primary Outcomes (1)

• Mean MADRS Total Score Change (Last Observation Carried Forward)

  The Montgomery-Asberg Depression Rating Scale (MADRS) will be performed as a baseline and endpoint assessments and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The MADRS score ranges from 0 to 60; a score of 0-6 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

  Baseline to week 6 reported

Secondary Outcomes (2)

• Mean HDRS-17 Total Score Change (Last Observation Carried Forward)

  Baseline and week 6

• Mean IDS-SR Score Change (Last Observation Carried Forward)

  Baseline through week 6

Study Arms (1)

sTMS active

EXPERIMENTAL

Treatment with the NEST Device

Device: NEST (NeoSync EEG Synchronized TMS)

Interventions

NEST (NeoSync EEG Synchronized TMS) DEVICE

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.

sTMS active

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age;
• 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);
• MADRS score ≥ 20;
• Duration of current episode \>4 weeks
• YMRS score ≤ 12;
• baseline EEG of sufficient quality for quantitative analysis processing;
• willing and able to adhere to the intensive treatment schedule and all required study visits;
• 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).

You may not qualify if:

• unable or unwilling to give informed consent;
• diagnosed with current primary psychotic disorder (rather than BD);
• diagnosed with current mania or hypomanic mood episode;
• history of moderate to severe substance use disorder within the past 6 months (except nicotine and caffeine);
• currently being treated with a stimulant;
• 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;
• 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;
• initiation of new antidepressant treatments (new medication, new device-based stimulation, or new psychotherapy) within 6 weeks prior to study baseline;
• 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;
• presence of implanted cardiac pacemakers, implanted medication pumps, or intracardiac lines;
• 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;
• clinically significant unstable medical condition;
• if female: pregnant, not using medically acceptable means of birth control, or currently breastfeeding;
• other condition, which in the judgment of the Investigator could prevent the subject from completion of the study;
• for participants in the MRI study: ferromagnetic metal implant or other contraindication to imaging in a 3 Tesla MRI;

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

There was no external funding obtained for this trial. Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Linda Carpenter
• Organization: Butler Hospital

Linda_Carpenter_MD@brown.edu

401-455-6349

Study Officials

• Linda Carpenter, MD

  Butler Hospital, Mood Disorders Research Program, Brown Department of Psychiatry and Human Behavior

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Mood Disorder Research Program

Model Details: Open label, unblinded treatment series, all participants receive active treatment with the investigational device (NeoSync sTMS), as adjunct to ongoing stable pharmacotherapy

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: July 21, 2016
• Study Start: May 1, 2016
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: April 9, 2020
• Results First Posted: April 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)