Trial Outcomes & Findings for TMS for Adults With Autism and Depression (NCT NCT02939560)
NCT ID: NCT02939560
Last Updated: 2019-10-01
Results Overview
Hamilton Depression Rating Scale (HAM-D) with 17 questions. Minimum score = 0, maximum 53. Higher scores mean more severe depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Baseline through Week 5
Results posted on
2019-10-01
Participant Flow
Participant milestones
| Measure |
rTMS
Participants will receive rTMS sessions according to the study protocol.
NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
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|---|---|
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Overall Study
STARTED
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13
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Overall Study
COMPLETED
|
10
|
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Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
rTMS
Participants will receive rTMS sessions according to the study protocol.
NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Protocol Violation
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
rTMS
n=13 Participants
Participants will receive rTMS sessions according to the study protocol.
NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=13 Participants
|
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Age, Categorical
Between 18 and 65 years
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13 Participants
n=13 Participants
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Age, Categorical
>=65 years
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0 Participants
n=13 Participants
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Age, Continuous
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25.5 years
n=13 Participants
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|
Sex: Female, Male
Female
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1 Participants
n=13 Participants
|
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Sex: Female, Male
Male
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12 Participants
n=13 Participants
|
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Region of Enrollment
United States
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13 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 5Hamilton Depression Rating Scale (HAM-D) with 17 questions. Minimum score = 0, maximum 53. Higher scores mean more severe depression.
Outcome measures
| Measure |
rTMS
n=10 Participants
Participants will receive rTMS sessions according to the study protocol.
NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
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|---|---|
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Change From Baseline in Hamilton Depression Rating Scale
Baseline
|
21.5 score on a scale
Standard Deviation 4.3
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Change From Baseline in Hamilton Depression Rating Scale
Week 5
|
10.2 score on a scale
Standard Deviation 6.5
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PRIMARY outcome
Timeframe: Baseline, Week 5, Week 9, Week 17Aberrant Behavior Checklist. Minimum 0, maximum 174. Higher scores indicate worse behaviors.
Outcome measures
| Measure |
rTMS
n=10 Participants
Participants will receive rTMS sessions according to the study protocol.
NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
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|---|---|
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Change From Baseline in Aberrant Behavior Checklist
Baseline
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53 score on a scale
Standard Deviation 28
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Change From Baseline in Aberrant Behavior Checklist
Week 5
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24 score on a scale
Standard Deviation 16
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Change From Baseline in Aberrant Behavior Checklist
Week 9
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20 score on a scale
Standard Deviation 21
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Change From Baseline in Aberrant Behavior Checklist
Week 17
|
30 score on a scale
Standard Deviation 28
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PRIMARY outcome
Timeframe: Baseline, Week 5, Week 9, Week 17Social Responsiveness Scale-2. Minimum 0, maximum 195. Higher indicates worse behaviors
Outcome measures
| Measure |
rTMS
n=10 Participants
Participants will receive rTMS sessions according to the study protocol.
NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
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|---|---|
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Change From Baseline in Social Responsiveness Scale-2
Baseline
|
70.5 score on a scale
Standard Deviation 10.6
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Change From Baseline in Social Responsiveness Scale-2
Week 5
|
70.1 score on a scale
Standard Deviation 14.3
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Change From Baseline in Social Responsiveness Scale-2
Week 9
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66.0 score on a scale
Standard Deviation 16.6
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Change From Baseline in Social Responsiveness Scale-2
Week 17
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66.9 score on a scale
Standard Deviation 15.0
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PRIMARY outcome
Timeframe: Baseline, Week 5, Week 9, Week 17Ritvo Autism-Aspergers Diagnostic Scale. Minimum 0, maximum 240. Higher indicates worse symptoms.
Outcome measures
| Measure |
rTMS
n=10 Participants
Participants will receive rTMS sessions according to the study protocol.
NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
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|---|---|
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Change From Baseline in Ritvo Autism-Aspergers Diagnostic Scale
Baseline
|
38 score on a scale
Standard Deviation 11
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Change From Baseline in Ritvo Autism-Aspergers Diagnostic Scale
Week 5
|
38 score on a scale
Standard Deviation 15
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|
Change From Baseline in Ritvo Autism-Aspergers Diagnostic Scale
Week 9
|
39 score on a scale
Standard Deviation 14
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Change From Baseline in Ritvo Autism-Aspergers Diagnostic Scale
Week 17
|
39 score on a scale
Standard Deviation 15
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PRIMARY outcome
Timeframe: Baseline, Week 5, Week 9, Week 17Repetitive Behavior Scale-Revised Global Impression. Minimum 0, maximum 100. Higher indicates worse behaviors
Outcome measures
| Measure |
rTMS
n=10 Participants
Participants will receive rTMS sessions according to the study protocol.
NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
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|---|---|
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Change From Baseline in Repetitive Behavior Scale-Revised
Baseline
|
59 units on a scale
Standard Deviation 26
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Change From Baseline in Repetitive Behavior Scale-Revised
Week 5
|
26 units on a scale
Standard Deviation 25
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Change From Baseline in Repetitive Behavior Scale-Revised
Week 9
|
27 units on a scale
Standard Deviation 22
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Change From Baseline in Repetitive Behavior Scale-Revised
Week 17
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30 units on a scale
Standard Deviation 18
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SECONDARY outcome
Timeframe: Baseline, Week 5Population: Unable to obtain due to lack of available equipment.
Functional MRI data during cognitive processing tasks
Outcome measures
Outcome data not reported
Adverse Events
rTMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rTMS
n=13 participants at risk
Participants will receive rTMS sessions according to the study protocol.
NeuroStar® TMS device (Neuronetics, Atlanta, GA): Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
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|---|---|
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Nervous system disorders
Seizure
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7.7%
1/13 • Number of events 1 • Baseline to 17 weeks
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Additional Information
McLeod F. Gwynette, MD
Medical University of South Carolina
Phone: 843-792-9162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place