- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839798
NeoSync TMS Treatment for Bipolar I Depression (NESTTBID)
March 31, 2020 updated by: Linda L Carpenter MD, Butler Hospital
Evaluation of NeoSync EEG Synchronized TMS For the Treatment of Major Depressive Episode in Bipolar Disorder and Associated Neural Response: An Open Label Trial
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Butler Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sTMS active
Treatment with the NEST 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to week 6 reported
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean HDRS-17 Total Score Change (Last Observation Carried Forward)
Time Frame: Baseline and week 6
|
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.
|
Baseline and week 6
|
Mean IDS-SR Score Change (Last Observation Carried Forward)
Time Frame: Baseline through week 6
|
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.
|
Baseline through week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Linda Carpenter, MD, Butler Hospital, Mood Disorders Research Program, Brown Department of Psychiatry and Human Behavior
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
November 19, 2018
Study Completion (Actual)
November 19, 2018
Study Registration Dates
First Submitted
June 7, 2016
First Submitted That Met QC Criteria
July 18, 2016
First Posted (Estimate)
July 21, 2016
Study Record Updates
Last Update Posted (Actual)
April 9, 2020
Last Update Submitted That Met QC Criteria
March 31, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1601-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mood Disorders
-
Université du Québec a MontréalCiusss de L'Est de l'Île de Montréal; PhysioExtra; EnergirRecruitingDepression ; Anxiety With Depressed Mood ; Mood Disorder, Adjustment Disorder With Depressed MoodCanada
-
Joliet Center for Clinical ResearchAbbottCompleted
-
National Institute of Mental Health (NIMH)Completed
-
National Institute of Mental Health (NIMH)Completed
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of Colorado, DenverCompletedMood Disorders | Irritable MoodUnited States
-
VA Office of Research and DevelopmentCompleted
-
Baskent UniversityZİYAFET UĞURLURecruitingDisaster; Personality | Disorder, MoodTurkey
-
Fayoum University HospitalCompletedKetamine-Induced Mood DisorderEgypt
-
Mayo ClinicCompletedMood Disorders in Children and AdolescentsUnited States
Clinical Trials on NEST (NeoSync EEG Synchronized TMS)
-
Providence VA Medical CenterWave NeuroscienceCompleted
-
Wave NeuroscienceCompletedMajor Depressive DisorderUnited States
-
Wave NeuroscienceCompletedMajor Depressive Disorder (MDD)United States, China
-
National Institute of Neurological Disorders and...Completed
-
National Institute of Neurological Disorders and...CompletedElectrical Stimulation of the BrainUnited States
-
Medical University of South CarolinaColumbia University; University of Wisconsin, Madison; University of Oklahoma; Defense...Not yet recruiting
-
Wave NeuroscienceRecruitingStress Disorders, Post-TraumaticUnited States
-
QuantalX NeuroscienceCompletedStroke | Healthy | Cognitive Impairment | Dementia | Fibromyalgia | Cognitive Decline | MCI | TBI | Adhd | PDD | Ptsd | ABDIsrael
-
Rennes University HospitalCompleted