Trial Outcomes & Findings for Using Combined EEG and Non-invasive Brain Stimulation to Examine and Improve Reward Functioning in Opioid Use Disorder (NCT NCT04432493)

Last Updated: 2024-03-08

Results Overview

The reward positivity is an event-related brain potential, sensitive to reward feedback. The reward positivity will be measured during the t-maze task, where participants will receive feedback on choices (Reward, No-reward). Reward positivity amplitude will be determined by identifying the maximum absolute amplitude of the difference wave within a 200- to 400-ms window following feedback onset. The reward positivity will be evaluated along front-central electrodes (Fz, FCz, Cz).

Recruitment status

COMPLETED

Study phase

Target enrollment

81 participants

Primary outcome timeframe

Day 0 (day of testing)

Results posted on

2024-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Active TMS - OUD OUD Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined DLFPC target for a total of 2000 pulses Active repetitive transcranial magnetic stimulation (rTMS): rTMS will be used to stimulate neuronal activity of the dorsolateral prefrontal cortex (DLPFC). Participants will receive no more than 2000 pulses of rTMS at 110% of participants' resting motor threshold at 10 Hz continuously for the duration of the t-maze task.	Sham TMS - OUD Identical parameters will be applied to the OUD SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation Sham repetitive transcranial magnetic stimulation (rTMS): Sham TMS will be used to mimic the auditory sensation of the Active rTMS condition. Protocols for the sham condition will be the same as the active condition, however the TMS coil will be flipped 180 degrees so that participants in this condition will not receive any active stimulation.	Active TMS - HC Health Control (HC) Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined DLFPC target for a total of 2000 pulses Active repetitive transcranial magnetic stimulation (rTMS): rTMS will be used to stimulate neuronal activity of the dorsolateral prefrontal cortex (DLPFC). Participants will receive no more than 2000 pulses of rTMS at 110% of participants' resting motor threshold at 10 Hz continuously for the duration of the t-maze task.	Sham TMS - HC Identical parameters will be applied to the healthy control (HC) SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation Sham repetitive transcranial magnetic stimulation (rTMS): Sham TMS will be used to mimic the auditory sensation of the Active rTMS condition. Protocols for the sham condition will be the same as the active condition, however the TMS coil will be flipped 180 degrees so that participants in this condition will not receive any active stimulation.
Overall Study STARTED	16	18	22	25
Overall Study COMPLETED	16	18	22	25
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Combined EEG and Non-invasive Brain Stimulation to Examine and Improve Reward Functioning in Opioid Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active TMS - OUD n=16 Participants Opioid Use Disorder (OUD) Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined DLFPC target for a total of 2000 pulses Active repetitive transcranial magnetic stimulation (rTMS): rTMS will be used to stimulate neuronal activity of the dorsolateral prefrontal cortex (DLPFC). Participants will receive no more than 2000 pulses of rTMS at 110% of participants' resting motor threshold at 10 Hz continuously for the duration of the t-maze task.	Sham TMS - OUD n=18 Participants Identical parameters will be applied to the Opioid Use Disorder (OUD) SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation Sham repetitive transcranial magnetic stimulation (rTMS): Sham TMS will be used to mimic the auditory sensation of the Active rTMS condition. Protocols for the sham condition will be the same as the active condition, however the TMS coil will be flipped 180 degrees so that participants in this condition will not receive any active stimulation.	Active TMS - HC n=22 Participants Healthy Control (HC) Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined DLFPC target for a total of 2000 pulses Active repetitive transcranial magnetic stimulation (rTMS): rTMS will be used to stimulate neuronal activity of the dorsolateral prefrontal cortex (DLPFC). Participants will receive no more than 2000 pulses of rTMS at 110% of participants' resting motor threshold at 10 Hz continuously for the duration of the t-maze task.	Sham TMS - HC n=25 Participants Identical parameters will be applied to the Healthy Control (HC) SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation Sham repetitive transcranial magnetic stimulation (rTMS): Sham TMS will be used to mimic the auditory sensation of the Active rTMS condition. Protocols for the sham condition will be the same as the active condition, however the TMS coil will be flipped 180 degrees so that participants in this condition will not receive any active stimulation.	Total n=81 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	18 Participants n=7 Participants	22 Participants n=5 Participants	25 Participants n=4 Participants	81 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	42 years STANDARD_DEVIATION 9 • n=5 Participants	46 years STANDARD_DEVIATION 19 • n=7 Participants	36 years STANDARD_DEVIATION 12 • n=5 Participants	34 years STANDARD_DEVIATION 11 • n=4 Participants	39 years STANDARD_DEVIATION 11 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	33 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	48 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	40 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants	28 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	16 μV (Microvolts n=5 Participants	18 μV (Microvolts n=7 Participants	22 μV (Microvolts n=5 Participants	25 μV (Microvolts n=4 Participants	81 μV (Microvolts n=21 Participants

PRIMARY outcome

Timeframe: Day 0 (day of testing)

Outcome measures

Outcome measures
Measure	Active TMS - OUD n=16 Participants Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined DLFPC target for a total of 2000 pulses Active repetitive transcranial magnetic stimulation (rTMS): rTMS will be used to stimulate neuronal activity of the dorsolateral prefrontal cortex (DLPFC). Participants will receive no more than 2000 pulses of rTMS at 110% of participants' resting motor threshold at 10 Hz continuously for the duration of the t-maze task.	Sham TMS - OUD n=18 Participants Identical parameters will be applied to the SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation Sham repetitive transcranial magnetic stimulation (rTMS): Sham TMS will be used to mimic the auditory sensation of the Active rTMS condition. Protocols for the sham condition will be the same as the active condition, however the TMS coil will be flipped 180 degrees so that participants in this condition will not receive any active stimulation.	Active TMS - Controls n=22 Participants Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined DLFPC target for a total of 2000 pulses Active repetitive transcranial magnetic stimulation (rTMS): rTMS will be used to stimulate neuronal activity of the dorsolateral prefrontal cortex (DLPFC). Participants will receive no more than 2000 pulses of rTMS at 110% of participants' resting motor threshold at 10 Hz continuously for the duration of the t-maze task.	Sham TMS - Controls n=24 Participants Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined DLFPC target for a total of 2000 pulses Active repetitive transcranial magnetic stimulation (rTMS): rTMS will be used to stimulate neuronal activity of the dorsolateral prefrontal cortex (DLPFC). Participants will receive no more than 2000 pulses of rTMS at 110% of participants' resting motor threshold at 10 Hz continuously for the duration of the t-maze task.
Reward Positivity	-5.2 μV (microvolts) Standard Deviation 2	-2.3 μV (microvolts) Standard Deviation 3	-4.4 μV (microvolts) Standard Deviation 3	-4.6 μV (microvolts) Standard Deviation 3

Adverse Events

Active TMS - OUD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham TMS - OUD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active TMS - Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham TMS - Controls

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

Travis Baker, PhD

Rutgers University

Phone: 18622503351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place