Pain, ChronicPhase 2NCT03310138
RTMS for Treatment of Pain and Craving
A Phase 2 study testing Real Transcranial Magnetic Stimulation in people with Pain, Chronic and Pain Acute, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic, Pain Acute
- What is being tested?
- Real Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2017to 12 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65
- currently prescribed prescription opiates for pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the detailed description
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:
- change in pain sensitivity levels in the pain assessment task and
- 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.
- Conditions
- Pain, Chronic, Pain Acute
- Being tested
- Real Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Keywords
- treatment, brain stimulation
- Medical subject headings
- Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Transcranial Magnetic StimulationDevice
Also called TMS
Transcranial magnetic stimulation (TMS) is a minimally invasive brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a figure-8 coil (lasting only microseconds) is able to focally stimulate the cortex by depolarizing superficial neurons, which induces electrical currents in the brain. TMS pulses that are delivered repetitively and rhythmically are referred to as repetitive TMS (rTMS). In this study TMS is being delivered with the MagVenture MagPro B60 coil.
Sham Transcranial Magnetic StimulationDevice
The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
| Study group | Role | What they receive |
|---|---|---|
| Dorsolateral Prefrontal Cortex | Active comparator | Intervention: Real Transcranial Magnetic Stimulation
Real Transcranial Magnetic Stimulation will be delivered to the left dorsolateral prefrontal cortex (10Hz, 110% of resting motor threshold) using a MagVenture MagPro B60 coil. Receives: Device: Real Transcranial Magnetic Stimulation |
| Motor Cortex | Active comparator | Intervention: Real Transcranial Magnetic Stimulation
Real Transcranial Magnetic Stimulation will be delivered to the left primary motor cortex (10Hz, 80% of resting motor threshold) using a MagVenture MagPro B60 coil. Receives: Device: Real Transcranial Magnetic Stimulation |
| Sham stimulation | Placebo comparator | Intervention: Sham Transcranial Magnetic Stimulation
Sham Transcranial Magnetic Stimulation will be delivered to the prefrontal cortex (10Hz, 110% of resting motor threshold) using the integrated sham system on the MagVenture MagPro B60 coil. Receives: Device: Sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal pain threshold
Quantitative Sensory Testing will be used to measure each participant's thresholds for sensory detection of heat, painfulness, and tolerance. The investigators will test the hypothesis that Real TMS has a larger effect on thermal pain threshold following 10 days of TMS than sham TMS.
Measured: Day 1 versus Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start6 Jul 2017
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colleen A Hanlon, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310138
- Sponsor's protocol ID
- 42186
- Status last verified
- Sep 2024
- First submitted
- 10 Oct 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data from the primary outcome measurement will be shared via manuscripts and after study completion by request to the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RTMS for Treatment of Pain and Craving
- ClinicalTrials.gov ID
- NCT03310138
- Acronym / sponsor ID
- 42186
- Conditions
- Pain, Chronic, Pain Acute
- Keywords
- treatment, brain stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- change in pain sensitivity levels in the pain assessment task and
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dorsolateral Prefrontal Cortex | Active comparator | Device: Real Transcranial Magnetic StimulationIntervention: Real Transcranial Magnetic Stimulation Real Transcranial Magnetic Stimulation will be delivered to the left dorsolateral prefrontal cortex (10Hz, 110% of resting motor threshold) using a MagVenture MagPro B60 coil. |
| Motor Cortex | Active comparator | Device: Real Transcranial Magnetic StimulationIntervention: Real Transcranial Magnetic Stimulation Real Transcranial Magnetic Stimulation will be delivered to the left primary motor cortex (10Hz, 80% of resting motor threshold) using a MagVenture MagPro B60 coil. |
| Sham stimulation | Placebo comparator | Device: Sham Transcranial Magnetic StimulationIntervention: Sham Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation will be delivered to the prefrontal cortex (10Hz, 110% of resting motor threshold) using the integrated sham system on the MagVenture MagPro B60 coil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-65
- currently prescribed prescription opiates for pain
Key exclusion criteria (6 listed)
- documented history of seizures
- unstable chronic medical illness
- currently using any medications known to lower seizure risk
- metal above the waist
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real Transcranial Magnetic StimulationAlso: TMSTranscranial magnetic stimulation (TMS) is a minimally invasive brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a figure-8 coil (lasting only microseconds) is able to focally stimulate the cortex by depolarizing superficial neurons, which induces electrical currents in the brain. TMS pulses that are delivered repetitively and rhythmically are referred to as repetitive TMS (rTMS). In this study TMS is being delivered with the MagVenture MagPro B60 coil. | Device | Dorsolateral Prefrontal Cortex, Motor Cortex |
| Sham Transcranial Magnetic StimulationThe MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil. | Device | Sham stimulation |
Primary outcome
Thermal pain threshold
Time frame: Day 1 versus Day 10
Quantitative Sensory Testing will be used to measure each participant's thresholds for sensory detection of heat, painfulness, and tolerance. The investigators will test the hypothesis that Real TMS has a larger effect on thermal pain threshold following 10 days of TMS than sham TMS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. The data from the primary outcome measurement will be shared via manuscripts and after study completion by request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen A Hanlon, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Real Transcranial Magnetic Stimulation in people with Pain, Chronic and Pain Acute, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal pain threshold (time frame: Day 1 versus Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.