Major Depressive EpisodePhase 2NESTTBIDNCT02839798

NeoSync TMS Treatment for Bipolar I Depression

A Phase 2 study testing NEST (NeoSync EEG Synchronized TMS) in people with Major Depressive Episode and Bipolar Depression, run by Butler Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Major Depressive Episode, Bipolar Depression, Bipolar Disorder
What is being tested?: NEST (NeoSync EEG Synchronized TMS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: May 2016to 19 Nov 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:

18 - 70 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).

Exclusion Criteria: Subjects will be excluded from study participation if one of the following exclusion criteria applies:

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;
past treatment with TMS therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Butler Hospital
Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: Evaluation of NeoSync EEG Synchronized TMS For the Treatment of Major Depressive Episode in Bipolar Disorder and Associated Neural Response: An Open Label Trial

Conditions: Major Depressive Episode, Bipolar Depression, Bipolar Disorder, Mood Disorders
Being tested: NEST (NeoSync EEG Synchronized TMS)
Keywords: sTMS, NEST, NeoSync, synchronous, non-invasive neuromodulation, TMS, transcranial magnetic stimulation, EEG, bipolar, depression
Medical subject headings: Bipolar Disorder, Mood Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02839798
Study group	Role	What they receive
sTMS active	Experimental	Treatment with the NEST Device Receives: Device: NEST (NeoSync EEG Synchronized TMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to week 6 reported

Secondary outcomes (2)

Mean HDRS-17 Total Score Change (Last Observation Carried Forward)
The Hamilton Rating Scale for Depression (HRSD-28) will be done at baseline and endpoint assessments. The HRSD-17 score, derived from the HRSD-28, will be analyzed. The HRSD-17 score ranges from 0-52; a score of 0-7 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.
Measured: Baseline and week 6
Mean IDS-SR Score Change (Last Observation Carried Forward)
The Inventory of Depressive Symptomatology (IDS-SR) will be performed as a baseline and after every 5 treatments. It's a standardized self-rating scale for depressive symptom severity used in many clinical trials. IDS-SR total score ranges from 0 to 84; a score of 0-13 is generally accepted to be within the normal range (or reflect clinical remission), while a score of 26 or higher indicates at least moderate severity. Single value was average mean IDS-SR score change.
Measured: Baseline through week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201619 Nov 2018

First posted21 Jul 2016 (estimated)
Study startMay 2016
Primary completion19 Nov 2018
Study completion19 Nov 2018

Why it stopped: Lack of funding and staffing

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02839798
Sponsor's protocol ID: 1601-004
Acronym: NESTTBID
Status last verified: Mar 2020
First submitted: 7 Jun 2016
Last updated: 9 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
RecruitingObservational study
Sensation Seeking and TMS Response in TRD
MDD, Severe Depression
Not yet recruiting
Evaluation of the Acceptability, Feasibility and Exploration of the Efficacy of an Integrated Care Pathway CARIBOU
Major Depressive Disorder (MDD)
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)

All Major Depressive Episode trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of NeoSync EEG Synchronized TMS For the Treatment of Major Depressive Episode in Bipolar Disorder and Associated Neural Response: An Open Label Trial
ClinicalTrials.gov ID: NCT02839798
Acronym / sponsor ID: NESTTBID / 1601-004
Conditions: Major Depressive Episode, Bipolar Depression, Bipolar Disorder, Mood Disorders
Keywords: sTMS, NEST, NeoSync, synchronous, non-invasive neuromodulation, TMS, transcranial magnetic stimulation, EEG
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of funding and staffing
Enrolment: 6 participants (actual)
Lead sponsor: Butler HospitalUniversity, hospital or other
Study start: May 2016
Primary completion: 19 Nov 2018 (actual)
Study completion: 19 Nov 2018 (actual)
First posted: 21 Jul 2016 (estimated)
Results: Posted 9 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open label, unblinded treatment series, all participants receive active treatment with the investigational device (NeoSync sTMS), as adjunct to ongoing stable pharmacotherapy

Arm	Type	Receives
sTMS active	Experimental	Device: NEST (NeoSync EEG Synchronized TMS)Treatment with the NEST Device

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NEST (NeoSync EEG Synchronized TMS)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.	Device	sTMS active

Primary outcome

Mean MADRS Total Score Change (Last Observation Carried Forward)
Time frame: Baseline to week 6 reported
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.

2 secondary outcomes

Mean HDRS-17 Total Score Change (Last Observation Carried Forward)
Time frame: Baseline and week 6
Mean IDS-SR Score Change (Last Observation Carried Forward)
Time frame: Baseline through week 6

Results and safety

Results posted to the registry on 9 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
sTMS Active	6	4

Primary outcome: Mean MADRS Total Score Change (Last Observation Carried Forward)

Time frame: Baseline to week 6 reported. Mean (Standard Deviation). Unit: score on a scale

Measure	sTMS Active n = 6
Value	-17.8 (12.2)

Population analysed: Signed consent and got at least one treatment session

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACTIVE sTMS	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Limitations and caveats (from the sponsor): There was no external funding obtained for this trial. Early termination leading to small numbers of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Major Depressive Episode

RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
RecruitingObservational study
Sensation Seeking and TMS Response in TRD
MDD, Severe Depression
Not yet recruiting
Evaluation of the Acceptability, Feasibility and Exploration of the Efficacy of an Integrated Care Pathway CARIBOU
Major Depressive Disorder (MDD)
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Linda Carpenter, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NEST (NeoSync EEG Synchronized TMS) in people with Major Depressive Episode and Bipolar Depression, run by Butler Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean MADRS Total Score Change (Last Observation Carried Forward) (time frame: Baseline to week 6 reported). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02839798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.