Bipolar Depression, Bipolar Disorder, Major Depressive Episode, Mood Disorders
Conditions
Keywords
sTMS, NEST, NeoSync, synchronous, non-invasive neuromodulation, TMS, transcranial magnetic stimulation, EEG, bipolar, depression
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.
Interventions
DEVICENEST (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.
Sponsors
Butler Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean MADRS Total Score Change (Last Observation Carried Forward) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean HDRS-17 Total Score Change (Last Observation Carried Forward) | 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. |
| Mean IDS-SR Score Change (Last Observation Carried Forward) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| sTMS Active Treatment with the NEST Device
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. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | sTMS Active |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| MADRS TOTAL SCORE | 39.5 units on a scale STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
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.
Time frame: Baseline to week 6 reported
Population: Signed consent and got at least one treatment session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| sTMS Active | Mean MADRS Total Score Change (Last Observation Carried Forward) | -17.8 score on a scale | Standard Deviation 12.2 |
Secondary
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.
Time frame: Baseline and week 6
Population: signed consent and completed at least 1 treatment session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| sTMS Active | Mean HDRS-17 Total Score Change (Last Observation Carried Forward) | -7.8 score on a scale | Standard Deviation 6.6 |
Secondary
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.
Time frame: Baseline through week 6
Population: signed consent and completed at least 1 treatment session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| sTMS Active | Mean IDS-SR Score Change (Last Observation Carried Forward) | -7.7 score on a scale | Standard Deviation 8.5 |