Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation as Treatment for Acute Suicidality in Adult Patients (NCT NCT02693743)
NCT ID: NCT02693743
Last Updated: 2021-05-18
Results Overview
Change in suicidal ideation between baseline assessment and following 3 day TMS trial.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
Within the 3 days of the TMS trial.
Results posted on
2021-05-18
Participant Flow
Participant milestones
| Measure |
Active rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered to the left PFC, defined as a location 6 cm (cm) anterior to the right hand motor thumb area. A research nurse will deliver the treatments. rTMS will be delivered with a figure-eight coil at 120% motor threshold, 10 Hertz (Hz), 5 s (s) train duration, 20 s intertrain interval for 50 min (6000 pulses) 3 times daily for 3 days (total 9 sessions, 54,000 stimuli).
repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.
|
Sham rTMS
Parameters for sham Repetitive Transcranial Magnetic Stimulation (rTMS) are identical to those for active stimulation except that aluminum plate blocks the propagation of a magnetic field. The sound and physical sensation is the same as with the active coil while been biologically inactive.
repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Active rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered to the left PFC, defined as a location 6 cm (cm) anterior to the right hand motor thumb area. A research nurse will deliver the treatments. rTMS will be delivered with a figure-eight coil at 120% motor threshold, 10 Hertz (Hz), 5 s (s) train duration, 20 s intertrain interval for 50 min (6000 pulses) 3 times daily for 3 days (total 9 sessions, 54,000 stimuli).
repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.
|
Sham rTMS
Parameters for sham Repetitive Transcranial Magnetic Stimulation (rTMS) are identical to those for active stimulation except that aluminum plate blocks the propagation of a magnetic field. The sound and physical sensation is the same as with the active coil while been biologically inactive.
repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Repetitive Transcranial Magnetic Stimulation as Treatment for Acute Suicidality in Adult Patients
Baseline characteristics by cohort
| Measure |
Active rTMS
n=1 Participants
Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered to the left PFC, defined as a location 6 cm (cm) anterior to the right hand motor thumb area. A research nurse will deliver the treatments. rTMS will be delivered with a figure-eight coil at 120% motor threshold, 10 Hertz (Hz), 5 s (s) train duration, 20 s intertrain interval for 50 min (6000 pulses) 3 times daily for 3 days (total 9 sessions, 54,000 stimuli).
repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.
|
Sham rTMS
Parameters for sham Repetitive Transcranial Magnetic Stimulation (rTMS) are identical to those for active stimulation except that aluminum plate blocks the propagation of a magnetic field. The sound and physical sensation is the same as with the active coil while been biologically inactive.
repetitive transcranial magnetic stimulation (rTMS): A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.
|
Total
n=1 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within the 3 days of the TMS trial.Population: No outcome measures were taken, subject did not receive TMS, due to technical difficulties. Subject was withdrawn by PI
Change in suicidal ideation between baseline assessment and following 3 day TMS trial.
Outcome measures
Outcome data not reported
Adverse Events
Active rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Favrin Smith
University of Arkansas for Medical Sciences
Phone: 1 (501) 526-8488
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place