Trial Outcomes & Findings for Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent (NCT NCT03681769)
NCT ID: NCT03681769
Last Updated: 2023-02-10
Results Overview
Based on pilot data, the investigators expect an interaction between treatment (DLPFC or MC rTMS) and time (Before vs. After rTMS) on reported painfulness using a quantitative sensory testing technique that determines thermal pain threshold.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Change from baseline to 16 weeks
Results posted on
2023-02-10
Participant Flow
Participant milestones
| Measure |
Intermittent Theta Burst Stimulation (iTBS) to the Left dlPFC
For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the dlPFC (middle frontal gyrus) (F3) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P).
iTBS to the left dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
|
Intermittent Theta Burst Stimulation (iTBS) to the Motor Cortex
For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the motor cortex (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P).
iTBS to the Motor Cortex: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent
Baseline characteristics by cohort
| Measure |
Intermittent Theta Burst Stimulation (iTBS) to the Left dlPFC
n=11 Participants
For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the dlPFC (middle frontal gyrus) (F3) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P).
iTBS to the left dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
|
Intermittent Theta Burst Stimulation (iTBS) to the Motor Cortex
n=11 Participants
For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the dlPFC (middle frontal gyrus) (F3) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P).
iTBS to the Motor Cortex: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
57.7 Years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
53.8 Years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 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: Change from baseline to 16 weeksBased on pilot data, the investigators expect an interaction between treatment (DLPFC or MC rTMS) and time (Before vs. After rTMS) on reported painfulness using a quantitative sensory testing technique that determines thermal pain threshold.
Outcome measures
| Measure |
Intermittent Theta Burst Stimulation (iTBS) to the Left dlPFC
n=11 Participants
For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the dlPFC (middle frontal gyrus) (F3) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P).
iTBS to the left dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
|
Intermittent Theta Burst Stimulation (iTBS) to the Motor Cortex
n=11 Participants
For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the Motor Cortex (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P).
iTBS to the Motor Cortex: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
|
|---|---|---|
|
Change in Quantitative Pain Testing Following Active TMS Compared to Baseline
|
1.4 Change from Baseline (degrees C)
Standard Deviation .3
|
.3 Change from Baseline (degrees C)
Standard Deviation .15
|
SECONDARY outcome
Timeframe: Patient reported pain/discomfort at 16 weeks.The investigators expect reductions in self reported pain assessment via a numeric pain rating scale when comparing active vs sham. Pain rating values will be assessed and reported through the duration of the study. Numeric Rating Scale (NRS) for pain has a range of 0 to 10 where 0=no pain/discomfort and 10=worst pain/discomfort imaginable. Higher scores mean more pain/discomfort.
Outcome measures
| Measure |
Intermittent Theta Burst Stimulation (iTBS) to the Left dlPFC
n=11 Participants
For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the dlPFC (middle frontal gyrus) (F3) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P).
iTBS to the left dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
|
Intermittent Theta Burst Stimulation (iTBS) to the Motor Cortex
n=11 Participants
For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the Motor Cortex (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P).
iTBS to the Motor Cortex: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
|
|---|---|---|
|
Change in Patient Reported Pain and Discomfort
|
5.3 score on a scale
Standard Deviation 2.4
|
5.9 score on a scale
Standard Deviation 2.0
|
Adverse Events
Intermittent Theta Burst Stimulation (iTBS) to the Left dlPFC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intermittent Theta Burst Stimulation (iTBS) to the Motor Cortex
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
Dr. Jeff Borckardt
Medical University of South Carolina
Phone: 843-792-3295
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place