Trial Outcomes & Findings for NeoSync TMS Treatment for Bipolar I Depression (NCT NCT02839798)
NCT ID: NCT02839798
Last Updated: 2020-04-09
Results Overview
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.
TERMINATED
PHASE2
6 participants
Baseline to week 6 reported
2020-04-09
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
NeoSync TMS Treatment for Bipolar I Depression
Baseline characteristics by cohort
| Measure |
sTMS Active
n=6 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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6 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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6 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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6 Participants
n=5 Participants
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MADRS TOTAL SCORE
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39.5 units on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline to week 6 reportedPopulation: Signed consent and got at least one treatment session
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.
Outcome measures
| Measure |
sTMS Active
n=6 Participants
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.
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|---|---|
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Mean MADRS Total Score Change (Last Observation Carried Forward)
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-17.8 score on a scale
Standard Deviation 12.2
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SECONDARY outcome
Timeframe: Baseline and week 6Population: signed consent and completed at least 1 treatment session
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.
Outcome measures
| Measure |
sTMS Active
n=6 Participants
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.
|
|---|---|
|
Mean HDRS-17 Total Score Change (Last Observation Carried Forward)
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-7.8 score on a scale
Standard Deviation 6.6
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SECONDARY outcome
Timeframe: Baseline through week 6Population: signed consent and completed at least 1 treatment session
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.
Outcome measures
| Measure |
sTMS Active
n=6 Participants
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.
|
|---|---|
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Mean IDS-SR Score Change (Last Observation Carried Forward)
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-7.7 score on a scale
Standard Deviation 8.5
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Adverse Events
ACTIVE sTMS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACTIVE sTMS
n=6 participants at risk
Active Open Label 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.
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|---|---|
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Nervous system disorders
dizziness or lightheadedness
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33.3%
2/6 • Number of events 2 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
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Nervous system disorders
panic or anxiety attack
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33.3%
2/6 • Number of events 2 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
|
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Nervous system disorders
headache
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50.0%
3/6 • Number of events 3 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
|
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Gastrointestinal disorders
Gastrointestinal upset or nausea
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33.3%
2/6 • Number of events 2 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
|
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Psychiatric disorders
Irritability
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16.7%
1/6 • Number of events 1 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
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Psychiatric disorders
Suicidal Ideation
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16.7%
1/6 • Number of events 1 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
|
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Psychiatric disorders
Diminished Attention
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16.7%
1/6 • Number of events 1 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
|
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Ear and labyrinth disorders
Sinus Congestion
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16.7%
1/6 • Number of events 1 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
|
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Surgical and medical procedures
Tooth Extraction
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16.7%
1/6 • Number of events 1 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
|
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Nervous system disorders
Paresthesia
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16.7%
1/6 • Number of events 1 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
|
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Skin and subcutaneous tissue disorders
Contusion
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16.7%
1/6 • Number of events 1 • From Treatment Session #1 until Treatment #30 (6 weeks or LOCF if early termination)
participants were queried at each treatment session
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place