Trial Outcomes & Findings for Imaging the Effects of rTMS on Chronic Pain (NCT NCT02687360)

NCT ID: NCT02687360

Last Updated: 2025-04-15

Results Overview

Number of participants with chronic pain and comorbid psychiatric disorders who complete 60% of sessions.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-04-15

Participant Flow

Participant milestones

Measure	Active rTMS Stimulation This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices. Active rTMS treatment: In the active treatment, magnetic power output will be delivered to the participants through the coils.	Sham rTMS Stimulation The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil and to produce activation of facial muscles similar to the effect of active rTMS without stimulating the brain itself. Sham rTMS treatment: The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
Overall Study STARTED	4	3
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Active rTMS Stimulation This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices. Active rTMS treatment: In the active treatment, magnetic power output will be delivered to the participants through the coils.	Sham rTMS Stimulation The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil and to produce activation of facial muscles similar to the effect of active rTMS without stimulating the brain itself. Sham rTMS treatment: The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Active rTMS Stimulation n=4 Participants This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices. Active rTMS treatment: In the active treatment, magnetic power output will be delivered to the participants through the coils.	Sham rTMS Stimulation n=3 Participants The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil and to produce activation of facial muscles similar to the effect of active rTMS without stimulating the brain itself. Sham rTMS treatment: The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	3 Participants n=3 Participants	7 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants
Age, Continuous	35 years STANDARD_DEVIATION 6 • n=4 Participants	39 years STANDARD_DEVIATION 5 • n=3 Participants	37 years STANDARD_DEVIATION 6 • n=7 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	1 Participants n=3 Participants	3 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	2 Participants n=3 Participants	4 Participants n=7 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	3 participants n=3 Participants	7 participants n=7 Participants

PRIMARY outcome

Timeframe: 3 months

Population: In this feasibility study all participants were included in determining feasibility.

Number of participants with chronic pain and comorbid psychiatric disorders who complete 60% of sessions.

Outcome measures

Measure	Active rTMS Stimulation n=4 Participants This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices. Active rTMS treatment: In the active treatment, magnetic power output will be delivered to the participants through the coils.	Sham rTMS Stimulation n=3 Participants The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil and to produce activation of facial muscles similar to the effect of active rTMS without stimulating the brain itself. Sham rTMS treatment: The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
Feasibility: Ability to Recruit and to Have Participants Complete the Study	4 Participants	3 Participants

Adverse Events

Active rTMS Stimulation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham rTMS Stimulation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active rTMS Stimulation n=4 participants at risk This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices. Active rTMS treatment: In the active treatment, magnetic power output will be delivered to the participants through the coils.	Sham rTMS Stimulation n=3 participants at risk The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil and to produce activation of facial muscles similar to the effect of active rTMS without stimulating the brain itself. Sham rTMS treatment: The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
Nervous system disorders headache	50.0% 2/4 • Number of events 2 • Participants were followed for 9 weeks.	66.7% 2/3 • Number of events 2 • Participants were followed for 9 weeks.

Additional Information

Diana Martinez

Columbia Univeristy

Phone: 646-774-6160

Email: dm437@cumc.columbia.edu

Results disclosure agreements

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