Trial Outcomes & Findings for Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning (NCT NCT03821337)

NCT ID: NCT03821337

Last Updated: 2022-12-21

Results Overview

Total number of rTMS sessions completed out of 6 sessions per day for three days over a three week period.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: Through study completion, an average of 3 weeks
• Results posted on: 2022-12-21

Participant Flow

Participant milestones

Measure	rTMS Participants will receive 18 sessions of active rTMS delivered at 120% rMT. repetitive Trans Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is able to alter cortical excitability and is FDA-approved to treat Major Depressive Disorder. Magnetic fields pass unimpeded through the scalp, skull and meninges, and can directly excite cortical areas.	Sham TMS Participants will receive 18 sessions of sham rTMS delivered through an inactive coil. Sham TMS: Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of TMS, combined with a TENS device which produces a small electric shock mimicking the feeling of real rTMS. This type of sham has been demonstrated to be indistinguishable from real rTMS, has been well tolerated (George et al., 2010; George et al., 2014) and successfully used in other clinical trials (Borckardt et al., 2008; Arana et al., 2008). During each session of rTMS the investigators will present a series of opioid related images, including those utilized in previous studies (Garland et al., 2015; Garland \& Howard, 2014).
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning

Baseline characteristics by cohort

Measure	rTMS n=1 Participants Participants will receive 18 sessions of active rTMS delivered at 120% rMT. repetitive Trans Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is able to alter cortical excitability and is FDA-approved to treat Major Depressive Disorder. Magnetic fields pass unimpeded through the scalp, skull and meninges, and can directly excite cortical areas.	Sham TMS Participants will receive 18 sessions of sham rTMS delivered through an inactive coil. Sham TMS: Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of TMS, combined with a TENS device which produces a small electric shock mimicking the feeling of real rTMS. This type of sham has been demonstrated to be indistinguishable from real rTMS, has been well tolerated (George et al., 2010; George et al., 2014) and successfully used in other clinical trials (Borckardt et al., 2008; Arana et al., 2008). During each session of rTMS the investigators will present a series of opioid related images, including those utilized in previous studies (Garland et al., 2015; Garland \& Howard, 2014).	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
Age, Continuous	55 Years STANDARD_DEVIATION NA • n=5 Participants	—	55 Years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 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
Region of Enrollment United States	1 Participants n=5 Participants	—	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 3 weeks

Population: Veterans being treated for opioid use disorder. Only one subject completed rTMS sessions and they were in the active rTMS group.

Total number of rTMS sessions completed out of 6 sessions per day for three days over a three week period.

Outcome measures

Measure	rTMS n=1 Participants Participants will receive 18 sessions of active rTMS delivered at 120% rMT. repetitive Trans Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is able to alter cortical excitability and is FDA-approved to treat Major Depressive Disorder. Magnetic fields pass unimpeded through the scalp, skull and meninges, and can directly excite cortical areas.	Sham TMS Participants will receive 18 sessions of sham rTMS delivered through an inactive coil. Sham TMS: Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of TMS, combined with a TENS device which produces a small electric shock mimicking the feeling of real rTMS. This type of sham has been demonstrated to be indistinguishable from real rTMS, has been well tolerated (George et al., 2010; George et al., 2014) and successfully used in other clinical trials (Borckardt et al., 2008; Arana et al., 2008). During each session of rTMS the investigators will present a series of opioid related images, including those utilized in previous studies (Garland et al., 2015; Garland \& Howard, 2014).
Retention: Total Number of rTMS Sessions Completed	18 Sessions completed	—

PRIMARY outcome

Timeframe: Through study completion, an average of 3 weeks

Population: Veterans receiving medication assisted treatment for opioid use disorder.

Number of adverse events experienced by Veterans receiving medication assisted treatment for opioid use disorder who undergo 18 sessions of active or sham rTMS.

Outcome measures

Measure	rTMS n=1 Participants Participants will receive 18 sessions of active rTMS delivered at 120% rMT. repetitive Trans Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is able to alter cortical excitability and is FDA-approved to treat Major Depressive Disorder. Magnetic fields pass unimpeded through the scalp, skull and meninges, and can directly excite cortical areas.	Sham TMS Participants will receive 18 sessions of sham rTMS delivered through an inactive coil. Sham TMS: Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of TMS, combined with a TENS device which produces a small electric shock mimicking the feeling of real rTMS. This type of sham has been demonstrated to be indistinguishable from real rTMS, has been well tolerated (George et al., 2010; George et al., 2014) and successfully used in other clinical trials (Borckardt et al., 2008; Arana et al., 2008). During each session of rTMS the investigators will present a series of opioid related images, including those utilized in previous studies (Garland et al., 2015; Garland \& Howard, 2014).
Tolerability: The Total Number of Treatment Emergent Adverse Events	1 Adverse Events	—

Adverse Events

rTMS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham TMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	rTMS n=1 participants at risk Participants will receive 18 sessions of active rTMS delivered at 120% rMT. repetitive Trans Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is able to alter cortical excitability and is FDA-approved to treat Major Depressive Disorder. Magnetic fields pass unimpeded through the scalp, skull and meninges, and can directly excite cortical areas.	Sham TMS Participants will receive 18 sessions of sham rTMS delivered through an inactive coil. Sham TMS: Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of TMS, combined with a TENS device which produces a small electric shock mimicking the feeling of real rTMS. This type of sham has been demonstrated to be indistinguishable from real rTMS, has been well tolerated (George et al., 2010; George et al., 2014) and successfully used in other clinical trials (Borckardt et al., 2008; Arana et al., 2008). During each session of rTMS the investigators will present a series of opioid related images, including those utilized in previous studies (Garland et al., 2015; Garland \& Howard, 2014).
Nervous system disorders Headache	100.0% 1/1 • Number of events 1 • Three weeks of once weekly treatment sessions. 0 participants were at risk for adverse events in the sham condition because no participants were randomized to that condition.	— 0/0 • Three weeks of once weekly treatment sessions. 0 participants were at risk for adverse events in the sham condition because no participants were randomized to that condition.

Additional Information

Program Manager

VA Medical Center

Phone: 843-792-0476

Email: lisa.nunn@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place