Trial Outcomes & Findings for rTMS for Stimulant Use Disorders (NCT NCT04907357)
NCT ID: NCT04907357
Last Updated: 2025-07-03
Results Overview
Treatment session attendance and completion will be tracked over the course of the study, and this record will constitute the primary feasibility outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
Sham (Placebo)
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Sham (Placebo): Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
|
rTMS
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
rTMS: Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
66
|
|
Overall Study
COMPLETED
|
51
|
45
|
|
Overall Study
NOT COMPLETED
|
12
|
21
|
Reasons for withdrawal
| Measure |
Sham (Placebo)
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Sham (Placebo): Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
|
rTMS
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
rTMS: Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
18
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Unable to attend visits
|
1
|
0
|
|
Overall Study
Incarcerated
|
1
|
1
|
Baseline Characteristics
rTMS for Stimulant Use Disorders
Baseline characteristics by cohort
| Measure |
rTMS
n=66 Participants
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
rTMS: Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
|
Sham (Placebo)
n=63 Participants
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Sham (Placebo): Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 10.20 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 9.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
63 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Primary substance of use
Cocaine
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Primary substance of use
Methamphetamine
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Major Depressive Episode
Present
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Major Depressive Episode
Absent
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first treatment session (Week 1, first study visit) to end of treatment at 8 weeksTreatment session attendance and completion will be tracked over the course of the study, and this record will constitute the primary feasibility outcome.
Outcome measures
| Measure |
rTMS
n=66 Participants
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
rTMS: Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
|
Sham (Placebo)
n=63 Participants
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Sham (Placebo): Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
|
|---|---|---|
|
Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period.
Attended 20 or more rTMS/sham sessions
|
29 Participants
|
40 Participants
|
|
Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period.
Attended fewer than 20 rTMS/sham sessions
|
37 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From first treatment week (Week 1) to end of treatment at 8 weeksA negative UDS for participants with cocaine as primary substance would be a UDS absent of cocaine; a negative UDS for participants with methamphetamine as primary substance would be a UDS absent of methamphetamine.
Outcome measures
| Measure |
rTMS
n=407 Urine drug screens
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
rTMS: Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
|
Sham (Placebo)
n=414 Urine drug screens
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Sham (Placebo): Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
|
|---|---|---|
|
Negative UDS From Weekly UDS
Negative UDS
|
38 Urine drug screens
|
30 Urine drug screens
|
|
Negative UDS From Weekly UDS
Positive UDS
|
369 Urine drug screens
|
384 Urine drug screens
|
Adverse Events
rTMS
Serious events: 5 serious events
Other events: 45 other events
Deaths: 1 deaths
Sham (Placebo)
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rTMS
n=66 participants at risk
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
rTMS: Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
|
Sham (Placebo)
n=63 participants at risk
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Sham (Placebo): Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
1.5%
1/66 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
0.00%
0/63 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Infections and infestations
Pulmonary sepsis
|
1.5%
1/66 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
0.00%
0/63 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Nervous system disorders
Cerebral vascular accident
|
1.5%
1/66 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
0.00%
0/63 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/66 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
0.00%
0/63 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/66 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
0.00%
0/63 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/66 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
1.6%
1/63 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/66 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
1.6%
1/63 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
Other adverse events
| Measure |
rTMS
n=66 participants at risk
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
rTMS: Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
|
Sham (Placebo)
n=63 participants at risk
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Sham (Placebo): Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.6%
7/66 • Number of events 10 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
9.5%
6/63 • Number of events 6 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Nervous system disorders
Dizziness
|
7.6%
5/66 • Number of events 5 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
3.2%
2/63 • Number of events 2 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.6%
5/66 • Number of events 5 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
6.3%
4/63 • Number of events 4 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/66 • Number of events 1 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
7.9%
5/63 • Number of events 5 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
2/66 • Number of events 3 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
6.3%
4/63 • Number of events 5 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/66 • Number of events 2 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
6.3%
4/63 • Number of events 4 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Nervous system disorders
Headache device related
|
7.6%
5/66 • Number of events 11 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
9.5%
6/63 • Number of events 9 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
General disorders
Application site discomfort
|
9.1%
6/66 • Number of events 7 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
3.2%
2/63 • Number of events 2 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
General disorders
Medical device site discomfort
|
10.6%
7/66 • Number of events 7 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
7.9%
5/63 • Number of events 5 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
General disorders
Medical Device Site Pain
|
28.8%
19/66 • Number of events 27 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
15.9%
10/63 • Number of events 12 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Eye disorders
Blepharospasm device related
|
6.1%
4/66 • Number of events 6 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
0.00%
0/63 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching device related
|
6.1%
4/66 • Number of events 5 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
4.8%
3/63 • Number of events 6 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
|
Injury, poisoning and procedural complications
Procedural Headache
|
7.6%
5/66 • Number of events 5 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
3.2%
2/63 • Number of events 2 • 16 weeks
Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
|
Additional Information
Kathleen Brady, MD, PhD
Medical University of South Carolina
Phone: 843-792-5205
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place