Developing rTMS Treatment Strategies for Pain in Opiate Dependence

NCT03576781 | Completed Early Phase 1 DMC

• 1 other identifier: 61328
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to parametically evaluate two different types of repetitive Transcranial Magnetic Stimulation (rTMS) treatment strategies as a potential treatment for pain in individuals currently taking prescription opiates. Repetitive TMS is a non-invasive tool that uses magnetic pulses to temporarily stimulate specific brain areas. This study will test whether rTMS over different locations of the prefrontal cortex can produce a reduction in an individuals perception of pain and how the brain responds to pain. Participants will be randomized to receive either sham-rTMS, or one of two real rTMS treatments. Brain imaging, behavioral assessments, and pain assessments will be collected both immediately before and after rTMS.

Conditions

Pain; Chronic Pain; Opioid Dependence; Opioid Use

Keywords

Brain Stimulation; Treatment

Outcome Measures

Primary Outcomes (1)

• iTBS to the left DLPFC vs. cTBS to the left MPFC

  The effect of real vs. sham iTBS to the left DLPFC vs. real vs. sham cTBS to the left MPFC as a tool to modulate the brain response to pain will be assessed by comparing the brain activity in the executive circuit and limbic circuit before and after TMS.

  Day 1

Secondary Outcomes (2)

• Changes in pain threshold

  Day 1

• Changes in opiate pain and craving inventory

  Day 1

Study Arms (4)

Real iTBS to the DLPFC

EXPERIMENTAL

One session of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)

Device: Real iTBS

Sham iTBS to the DLPFC

SHAM COMPARATOR

One session of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total)

Device: Sham iTBS

Real cTBS to the MPFC

EXPERIMENTAL

One session of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)

Device: Real cTBS

Sham cTBS to the MPFC

SHAM COMPARATOR

One session of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total)

Device: Sham cTBS

Interventions

Real iTBS DEVICE

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)

Real iTBS to the DLPFC

Sham iTBS DEVICE

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.

Sham iTBS to the DLPFC

Real cTBS DEVICE

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).

Real cTBS to the MPFC

Sham cTBS DEVICE

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.

Sham cTBS to the MPFC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and understand questionnaires and informed consent.
• Able to read and understand questionnaires and informed consent.
• Lives within 50 miles of the study site.
• Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold)
• Does not have metal objects in the head/neck.
• Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.
• Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

You may not qualify if:

• Any psychoactive illicit substance use (except marijuana and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels.
• Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder or organic mental disorder.
• Has current suicidal ideation or homicidal ideation.
• Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD.
• Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
• Has current charges pending for a violent crime (not including DUI related offenses).
• Does not have a stable living situation.
• Suffers from chronic migraines.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• South Carolina Clinical & Translational Research Institute (SCTR): collaborator

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Ralph H Johnson Veterans Medical Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Colleen A Hanlon, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 3, 2018
• Study Start: February 9, 2017
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)