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

March 5, 2024 updated by: Travis Baker, PhD, Rutgers University

The primary aims of this study are to identify impaired cognitive control in opioid use disorder (OUD) and subsequently to examine the effects of transcranial magnetic stimulation (TMS) on reward processing, as measured by the reward positivity (an electrophysiological signal) in people with OUD. To this end, the investigators will adopt a randomized sham-controlled trial to evaluate the efficacy of Ri-TMS on cognitive control in OUD.

The investigators hypothesize that Ri-TMS will be successful in modulating the reward positivity in opioid users in the active TMS condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The design is primarily a randomized control-trial design, comparing the effects of placebo (sham) and active TMS stimulation on reward processing across two groups of participants - healthy controls and opioid users.

Participants will be asked to engage in a virtual T-maze task, a reward-based choice task that elicits robust reward positivities. During this task participants will receive simultaneous EEG/TMS, while they engage in the virtual T-maze decision making task, used in our previous reward positivity studies on SUDs. ERPs will be recorded throughout the T-Maze task, and the reward positivity will be measured as the difference in maximum amplitude between reward and no-reward feedback conditions.

The TMS coil will be positioned using a an Adept Viper s850 robotic arm (SmartMove, ANT Neuro, Enschede, The Netherlands), providing precise targeting of the predetermined left dorsolateral prefrontal (DLPFC) coordinate (< 10 mm from the scalp, orientated at a 45º angle). Participants in the active TMS condition will receive rTMS pulses throughout the duration of the T-Maze task, with a maximum of 2000 pulses delivered to each participant. Identical parameters will be applied to the SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Rutgers University - Newark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Native English speakers
  • Males and Females aged 18-55 years old
  • Ability to provide informed written or verbal consent
  • Opioid dependent individuals (according to the Alcohol, Smoking and Substance Involvement Screening Test opioid dependence score), or
  • Healthy controls with no history of significant substance use

Exclusion Criteria:

  • Un-correctable visual impairment
  • Uninterruptable central nervous system medication
  • TMS contraindications (e.g., pregnancy, braces, history of seizures, metal implants).
  • History of neurological or psychiatric illness
  • Diagnosed learning disability
  • History of significant head injury (loss of consciousness for more than five minutes)
  • Substance abuse (Participants who score above 39.5 on the Global Continuum of Substance Risk scale of the Alcohol, Smoking and Substance Involvement Screening Test - controls only)
  • Use of psychoactive or vasoactive medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active TMS - OUD
Participants in the opioid used disorder group (OUD) 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
Device: 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.
Placebo Comparator: Sham TMS - OUD
Identical parameters will be applied to the opioid used disorder (OUD) SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation
Device: 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 Comparator: Active TMS - HC
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
Device: 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 Comparator: 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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reward Positivity
Time Frame: Day 0 (day of testing)
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).
Day 0 (day of testing)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers University

Investigators

  • Principal Investigator: Kathryn Biernacki, PhD, Rutgers University - Newark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2020

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2018002739

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data may be uploaded to an open source framework. All data will be de-identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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