Chronic PainEarly Phase 1NCT03681769
Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent
A Early Phase 1 study testing iTBS to the left dlPFC and cTBS to the mPFC in people with Chronic Pain and Opiate Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Effective control of chronic pain is a top priority in the United States, as approximately 10% of adults have severe chronic pain - most of which is chronic lower back pain (CLBP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Opiate Dependence, Lower Back Pain
- What is being tested?
- iTBS to the left dlPFC and cTBS to the mPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2019to 19 Mar 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 (to maximize participation)
- Currently using prescription opiates
- Able to read and understand questionnaires and informed consent.
- 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.
Who cannot join
- 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 Carboxy-Tetrahydrocannabinol levels.
- Meets Diagnostic and Statistical Manual of Mental Disorders 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 Attention Deficit Hyperactivity Disorder.
- Females of childbearing potential who are pregnant (by urine human chorionic gonadotropin level), nursing, or who are not using a reliable form of birth control.
- Has current charges pending for a violent crime (not including driving under the influence related offenses).
- Does not have a stable living situation.
- Suffers from chronic migraines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Effective control of chronic pain is a top priority in the United States, as approximately 10% of adults have severe chronic pain - most of which is chronic lower back pain (CLBP). However, despite the advances in neuroscience over the past 20 years, chronic pain is still largely treated with opiate narcotics, much as was done in the Civil War. In addition to the high abuse liability and dependence potential, only 30-40% of chronic pain patients declare they receive satisfactory (>50%) relief from their pain through pharmacological treatment. In these patients a common clinical practice is to escalate the dose of opiates as tolerance develops - which unfortunately has contributed to escalation in opiate overdose deaths, a resurgence of intravenous heroin use, and $55 billion in societal costs. Consequently there is a critical need for new, treatments that can treat pain and reduce reliance on opiates in individuals with chronic pain.
Aim 1. Evaluate repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: DLPFC TMS will attenuate the baseline brain response to pain (Pain Network activity) and increase activity in the Executive Control Network (ECN) when the patient is given instructions to 'control' the pain.
Aim 2. Evaluate Medial Prefrontal Cortex (MPFC) rTMS as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: MPFC TMS will also attenuate the baseline brain response to pain (Pain Network activity) but will not effect the ECN or the Salience Network (SN) when the patient is given instructions to 'control' the pain.
Read the detailed description
The goal of this proposal is to evaluate two novel non-invasive brain stimulation strategies to mitigate pain and the brain's response to pain in CLBP patients. Transcranial Magnetic Stimulation (TMS), can induce long term potentiation (LTP-like) and long term depression (LTD-like) effects on brain activity in a frequency dependent manner. The investigators have previously demonstrated that LTP-like TMS to the dorsolateral prefrontal cortex (DLPFC, a node in the Executive Control Network (ECN)) can decrease perceived pain and corresponding Blood Oxygen Level Dependent (BOLD) signal in the "Pain Network'. The Pain Network is an expansion of the Salience Network (SN; insula, dorsal anterior cingulate) which includes the thalamus and somatosensory cortex. The analgesic effects of DLPFC TMS can be blocked by naloxone - suggesting that the analgesic effects of LTP-like DLPFC TMS are opiate mediated. Additionally, DLPFC TMS delivered postoperatively leads to less patient administered morphine use (PCA-pump) in the hospital and less opiate use in the outpatient setting. These data all suggest that LTP-like DLPFC TMS is a promising candidate for treating pain.
An alternative strategy is to apply LTD-like stimulation to the medial prefrontal cortex (LTD-like mPFC rTMS. This strategy is based on the understanding of functional neural architecture, wherein the SN is modulated by two other core networks: the ECN and the default mode network (DMN). As stated above, it is possible to attenuate activity in the SN through LTP-like TMS to the DLPFC, a node in the ECN. It is also possible to attenuate the SN through LTD-like TMS to the ventral medial prefrontal cortex (a node in the DMN). The proposed study will be the first to employ a randomized, double-blind, sham-controlled design to parametrically evaluate the longitudinal effects of 16 days of rTMS to the DLPFC (Aim 1) or the MPFC (Aim 2) on self-reported pain and the brain's response to pain. This will be done in a cohort of patients recruited from the community as well as Medical University of South Carolina clinics with chronic lower back pain that may or may not be using prescription opiates for 3 or more months without adequate pain relief. Participants will be randomized to receive rTMS to the DLPFC (10Hz), MPFC (cTBS), or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected along with data from a standardized thermal pain paradigm wherein individuals are exposed to pain and instructed to try to "control' the pain. MRI data will be collected 3 times: before the 1st day of TMS, after the 12th day of TMS, and before the 16th day of TMS (the last day administered).
- Conditions
- Chronic Pain, Opiate Dependence, Lower Back Pain
- Being tested
- iTBS to the left dlPFC, Sham iTBS to the left dlPFC, cTBS to the mPFC, Sham cTBS to the mPFC
- Keywords
- Transcranial Magnetic Stimulation, Dorsolateral Prefrontal Cortex, Medial Prefrontal Cortex, Brain Stimulation
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS to the left dlPFCDevice
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
Sham iTBS to the left dlPFCDevice
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.
cTBS to the mPFCDevice
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)
Sham cTBS to the mPFCDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Theta Burst Stimulation (iTBS) to the left dlPFC | Experimental | For intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the dlPFC (middle frontal gyrus) (F3) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P). Receives: Device: iTBS to the left dlPFC |
| Sham iTBS to the left dlPFC | Sham comparator | The MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either real or sham stimulation. This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double-blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham (scale 1-10). Receives: Device: Sham iTBS to the left dlPFC |
| cTBS to the mPFC | Experimental | For continuous theta burst stimulation (Aim 2), participants will receive 1 train of stimulation over the left frontal pole (FP1) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P). This protocol has been shown to attenuate the mPFC and striatum in cocaine dependent individuals in the past (61-63) and has been more effective than 1200 or 1800 pulses of cTBS in attenuating depression (The time between the end of the TBS procedures and the beginning of the behavioral assessments, as well as the scalp-to-cortex distance (which effects the actual TMS dose given to the cortex) will be compiled and used as covariates in subsequent analyses. Receives: Device: cTBS to the mPFC |
| Sham cTBS to the mPFC | Sham comparator | The MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either real or sham stimulation. This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double-blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham (scale 1-10). Receives: Device: Sham cTBS to the mPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quantitative Pain Testing Following Active TMS Compared to Baseline
Based on pilot data, the investigators expect an interaction between treatment (DLPFC or MC rTMS) and time (Before vs. After rTMS) on reported painfulness using a quantitative sensory testing technique that determines thermal pain threshold.
Measured: Change from baseline to 16 weeks
Secondary outcomes (1)
Change in Patient Reported Pain and Discomfort
The investigators expect reductions in self reported pain assessment via a numeric pain rating scale when comparing active vs sham. Pain rating values will be assessed and reported through the duration of the study. Numeric Rating Scale (NRS) for pain has a range of 0 to 10 where 0=no pain/discomfort and 10=worst pain/discomfort imaginable. Higher scores mean more pain/discomfort.
Measured: Patient reported pain/discomfort at 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start22 Feb 2019
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized, double-blind, sham-controlled study will parametrically evaluate the longitudinal effects of 16 days of rTMS to the DLPFC (Aim 1) or the MPFC (Aim 2) on self-reported pain and the brain's response to pain. This will be done in a cohort of patients recruited from Medical University of South Carolina clinics and the outer community with chronic lower back pain that have been using prescription opiates for 3 or more months without adequate pain relief. Participants will be randomized to receive TMS to the DLPFC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected along with data from a standardized thermal pain paradigm wherein individuals are exposed to pain and instructed to try to "control' the pain. Quantitative Pain Testing will be collected 12 times. MRI data will be collected 3 times: before the 1st visit of TMS, before the 12th visit of TMS, and before the 16th visit of TMS.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Borckardt, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681769
- Sponsor's protocol ID
- 00078668
- Other IDs
- UG3DA048506, R21DA044503
- Status last verified
- Jan 2023
- First submitted
- 17 Sep 2018
- Last updated
- 10 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent
- ClinicalTrials.gov ID
- NCT03681769
- Acronym / sponsor ID
- 00078668
- Conditions
- Chronic Pain, Opiate Dependence, Lower Back Pain
- Keywords
- Transcranial Magnetic Stimulation, Dorsolateral Prefrontal Cortex, Medial Prefrontal Cortex, Brain Stimulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Posted 10 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective control of chronic pain is a top priority in the United States, as approximately 10% of adults have severe chronic pain - most of which is chronic lower back pain (CLBP). However, despite the advances in neuroscience over the past 20 years, chronic pain is still largely treated with opiate narcotics, much as was done in the Civil War. In addition to the high abuse liability and dependence potential, only 30-40% of chronic pain patients declare they receive satisfactory (>50%) relief from their pain through pharmacological treatment. In these patients a common clinical practice is to escalate the dose of opiates as tolerance develops - which unfortunately has contributed to escalation in opiate overdose deaths, a resurgence of intravenous heroin use, and $55 billion in societal costs. Consequently there is a critical need for new, treatments that can treat pain and reduce reliance on opiates in individuals with chronic pain.
Aim 1. Evaluate repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: DLPFC TMS will attenuate the baseline brain response to pain (Pain Network activity) and increase activity in the Executive Control Network (ECN) when the patient is given instructions to 'control' the pain.
Aim 2. Evaluate Medial Prefrontal Cortex (MPFC) rTMS as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: MPFC TMS will also attenuate the baseline brain response to pain (Pain Network activity) but will not effect the ECN or the Salience Network (SN) when the patient is given instructions to 'control' the pain.
Detailed description
The goal of this proposal is to evaluate two novel non-invasive brain stimulation strategies to mitigate pain and the brain's response to pain in CLBP patients. Transcranial Magnetic Stimulation (TMS), can induce long term potentiation (LTP-like) and long term depression (LTD-like) effects on brain activity in a frequency dependent manner. The investigators have previously demonstrated that LTP-like TMS to the dorsolateral prefrontal cortex (DLPFC, a node in the Executive Control Network (ECN)) can decrease perceived pain and corresponding Blood Oxygen Level Dependent (BOLD) signal in the "Pain Network'. The Pain Network is an expansion of the Salience Network (SN; insula, dorsal anterior cingulate) which includes the thalamus and somatosensory cortex. The analgesic effects of DLPFC TMS can be blocked by naloxone - suggesting that the analgesic effects of LTP-like DLPFC TMS are opiate mediated. Additionally, DLPFC TMS delivered postoperatively leads to less patient administered morphine use (PCA-pump) in the hospital and less opiate use in the outpatient setting. These data all suggest that LTP-like DLPFC TMS is a promising candidate for treating pain.
An alternative strategy is to apply LTD-like stimulation to the medial prefrontal cortex (LTD-like mPFC rTMS. This strategy is based on the understanding of functional neural architecture, wherein the SN is modulated by two other core networks: the ECN and the default mode network (DMN). As stated above, it is possible to attenuate activity in the SN through LTP-like TMS to the DLPFC, a node in the ECN. It is also possible to attenuate the SN through LTD-like TMS to the ventral medial prefrontal cortex (a node in the DMN). The proposed study will be the first to employ a randomized, double-blind, sham-controlled design to parametrically evaluate the longitudinal effects of 16 days of rTMS to the DLPFC (Aim 1) or the MPFC (Aim 2) on self-reported pain and the brain's response to pain. This will be done in a cohort of patients recruited from the community as well as Medical University of South Carolina clinics with chronic lower back pain that may or may not be using prescription opiates for 3 or more months without adequate pain relief. Participants will be randomized to receive rTMS to the DLPFC (10Hz), MPFC (cTBS), or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected along with data from a standardized thermal pain paradigm wherein individuals are exposed to pain and instructed to try to "control' the pain. MRI data will be collected 3 times: before the 1st day of TMS, after the 12th day of TMS, and before the 16th day of TMS (the last day administered).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This randomized, double-blind, sham-controlled study will parametrically evaluate the longitudinal effects of 16 days of rTMS to the DLPFC (Aim 1) or the MPFC (Aim 2) on self-reported pain and the brain's response to pain. This will be done in a cohort of patients recruited from Medical University of South Carolina clinics and the outer community with chronic lower back pain that have been using prescription opiates for 3 or more months without adequate pain relief. Participants will be randomized to receive TMS to the DLPFC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected along with data from a standardized thermal pain paradigm wherein individuals are exposed to pain and instructed to try to "control' the pain. Quantitative Pain Testing will be collected 12 times. MRI data will be collected 3 times: before the 1st visit of TMS, before the 12th visit of TMS, and before the 16th visit of TMS.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Theta Burst Stimulation (iTBS) to the left dlPFC | Experimental | Device: iTBS to the left dlPFCFor intermittent theta burst stimulation (iTBS) (Aim 1), participants will receive 20 trains of stimulation over the dlPFC (middle frontal gyrus) (F3) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P). |
| Sham iTBS to the left dlPFC | Sham comparator | Device: Sham iTBS to the left dlPFCThe MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either real or sham stimulation. This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double-blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham (scale 1-10). |
| cTBS to the mPFC | Experimental | Device: cTBS to the mPFCFor continuous theta burst stimulation (Aim 2), participants will receive 1 train of stimulation over the left frontal pole (FP1) (each train: 3 pulse bursts presented at 5 hertz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% resting motor threshold, MagPro; 600 pulses total) using a figure 8 coil (Coil Cool-B65 A/P). This protocol has been shown to attenuate the mPFC and striatum in cocaine dependent individuals in the past (61-63) and has been more effective than 1200 or 1800 pulses of cTBS in attenuating depression (The time between the end of the TBS procedures and the beginning of the behavioral assessments, as well as the scalp-to-cortex distance (which effects the actual TMS dose given to the cortex) will be compiled and used as covariates in subsequent analyses. |
| Sham cTBS to the mPFC | Sham comparator | Device: Sham cTBS to the mPFCThe MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either real or sham stimulation. This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double-blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham (scale 1-10). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 75 (to maximize participation)
- Currently using prescription opiates
- Able to read and understand questionnaires and informed consent.
- 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.
Key exclusion criteria (8 listed)
- 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 Carboxy-Tetrahydrocannabinol levels.
- Meets Diagnostic and Statistical Manual of Mental Disorders 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 Attention Deficit Hyperactivity Disorder.
- Females of childbearing potential who are pregnant (by urine human chorionic gonadotropin level), nursing, or who are not using a reliable form of birth control.
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 |
|---|---|---|
| iTBS to the left dlPFCThis will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key). | Device | Intermittent Theta Burst Stimulation (iTBS) to the left dlPFC |
| Sham iTBS to the left dlPFCThis 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. | Device | Sham iTBS to the left dlPFC |
| cTBS to the mPFCThis will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key) | Device | cTBS to the mPFC |
| Sham cTBS to the mPFCThis 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. | Device | Sham cTBS to the mPFC |
Primary outcome
Change in Quantitative Pain Testing Following Active TMS Compared to Baseline
Time frame: Change from baseline to 16 weeks
Based on pilot data, the investigators expect an interaction between treatment (DLPFC or MC rTMS) and time (Before vs. After rTMS) on reported painfulness using a quantitative sensory testing technique that determines thermal pain threshold.
1 secondary outcome
Change in Patient Reported Pain and Discomfort
Time frame: Patient reported pain/discomfort at 16 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jeffrey Borckardt, 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 Early Phase 1 study testing iTBS to the left dlPFC and cTBS to the mPFC in people with Chronic Pain and Opiate Dependence, 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 7 inclusion and 8 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 10 Feb 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Quantitative Pain Testing Following Active TMS Compared to Baseline (time frame: Change from baseline to 16 weeks). 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 10 Feb 2023.