rTMS for Treatment of Pain and Craving
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/25/2018 |
| Start Date: | July 6, 2017 |
| End Date: | July 2020 |
| Contact: | Colleen A Hanlon, PhD |
| Email: | hanlon@musc.edu |
| Phone: | 843-792-5732 |
The purpose of this study is to develop repetitive transcranial magnetic stimulation (rTMS)
as a potential treatment for pain in individuals on prescription opioid medication.
Repetitive TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate
specific brain areas in awake people (without the need for surgery, anesthetic, or other
invasive procedures). This study will test whether 10 days of rTMS over the prefrontal cortex
can produce a reduction in perception of pain and the desire to use opiates. TMS has been
approved by the FDA as an investigational tool as well a therapy for depression.
as a potential treatment for pain in individuals on prescription opioid medication.
Repetitive TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate
specific brain areas in awake people (without the need for surgery, anesthetic, or other
invasive procedures). This study will test whether 10 days of rTMS over the prefrontal cortex
can produce a reduction in perception of pain and the desire to use opiates. TMS has been
approved by the FDA as an investigational tool as well a therapy for depression.
Individuals between the ages of 18 and 65 with current (past 3 months) prescription opioid
use and chronic pain are being recruited. Participants will be screened on the telephone for
major inclusion/exclusion criteria. Individuals meeting inclusion criteria based on the
screening assessment will be set up for an appointment in the clinic. Participants will be
instructed not to use alcohol, prescription opioids, or any other drugs on the day of their
appointment. All study procedures will take place at the 30 Bee Street location of the Brain
Stimulation Lab (BSL). The protocol contains 1 screening visit, 10 TMS visit, and 2 follow up
visits. Individuals that are eligible following the screening visit will be randomized to
receive real or sham TMS.
On each TMS visit participants will undergo a single 20-minute session of 10Hz real or sham
rTMS (on-time=5 secs, off-time=10 secs) at up to 110% of resting motor threshold using a
MagVenture MagPro TMS machine.
Primary outcomes will be:
1. change in pain sensitivity levels in the pain assessment task and
2. change in levels of opiate craving.
The investigators will use analysis of variance models with group (real rTMS vs. sham) as the
between-subjects factor and time (pre- to post-TMS) as a within-subject factor. The
investigators will test the hypothesis that rTMS will result in significantly lower levels of
reported pain sensitivity and craving, as compared to sham. Blind interim analyses of the
data will be conducted when 50% of the sample has been accrued.
use and chronic pain are being recruited. Participants will be screened on the telephone for
major inclusion/exclusion criteria. Individuals meeting inclusion criteria based on the
screening assessment will be set up for an appointment in the clinic. Participants will be
instructed not to use alcohol, prescription opioids, or any other drugs on the day of their
appointment. All study procedures will take place at the 30 Bee Street location of the Brain
Stimulation Lab (BSL). The protocol contains 1 screening visit, 10 TMS visit, and 2 follow up
visits. Individuals that are eligible following the screening visit will be randomized to
receive real or sham TMS.
On each TMS visit participants will undergo a single 20-minute session of 10Hz real or sham
rTMS (on-time=5 secs, off-time=10 secs) at up to 110% of resting motor threshold using a
MagVenture MagPro TMS machine.
Primary outcomes will be:
1. change in pain sensitivity levels in the pain assessment task and
2. change in levels of opiate craving.
The investigators will use analysis of variance models with group (real rTMS vs. sham) as the
between-subjects factor and time (pre- to post-TMS) as a within-subject factor. The
investigators will test the hypothesis that rTMS will result in significantly lower levels of
reported pain sensitivity and craving, as compared to sham. Blind interim analyses of the
data will be conducted when 50% of the sample has been accrued.
Inclusion Criteria:
- age 18-65
- currently prescribed prescription opiates for pain
Exclusion Criteria:
- documented history of seizures
- unstable chronic medical illness
- currently using any medications known to lower seizure risk
- metal above the waist
- pregnancy
- history of a negative reaction to TMS
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-5732
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