Chronic PainNCT04156802
Project Relief: Developing Brain Stimulation as a Treatment for Chronic Pain
A study testing Real TBS to the mPFC and Real TBS to the MC in people with Chronic Pain and Chronic Lower Back Pain, run by Wake Forest University Health Sciences 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, Chronic Lower Back Pain, Back Pain
- What is being tested?
- Real TBS to the mPFC and Real TBS to the MC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 6 Jul 2022
- Phase
- Interventional
- 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 18-75 (to maximize participation)
- Can currently be 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.
- Meets DSM V criteria for current axis I disorders of obsessive-compulsive disorder, 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27101
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 largely treated with opiate narcotics, much as was done in the Civil War. In addition to their 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.
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 Repetitive transcranial magnetic stimulation (rTMS) to the primary motor cortex (MC) or the medial prefrontal cortex (MPFC) 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 Wake Forest Baptist Health (WFBH) clinics with chronic lower back pain that have not been able to find adequate pain relief, whether or not they are using prescription opiates for 3 or more months. Participants will be randomized to receive rTMS to the MC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity 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).
Read the detailed description
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 largely treated with opiate narcotics, much as was done in the Civil War. In addition to their 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.
The goal of this proposal is to evaluate 2 novel non-invasive brain stimulation strategies to mitigate pain and the brain's response to pain in CLBP patients that are currently taking chronic opiates, or that are seeking an alternative treatment for pain. 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. Our group has 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 our understanding of functional neural architecture, wherein the SN is modulated by 2 other core networks: the executive control network (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 MC or the MPFC 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 WFBH clinics with chronic lower back pain that have not been able to find adequate pain relief, whether or not they are using prescription opiates for 3 or more months. Participants will be randomized to receive rTMS to the MC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity 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).
Aim 1. Evaluate MC rTMS as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: MC TMS will attenuate the baseline brain response to pain (Pain Network activity) and increase activity in the ECN when the patient is given instructions to 'control' the pain.
Aim 2. Evaluate 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 SN when the patient is given instructions to 'control' the pain.
(Exploratory Aim): The investigator will evaluate if there are rate-dependent effects between baseline SN connectivity with the ECN and DMN and the efficacy of each TMS strategy on subjective pain. Data will be analyzed by using multivariate pattern analysis (MVPA). While the primary outcomes will be magnetic resonance imaging (MRI) Visit 1 versus Visit 2, the investigator will also examine the relative 'durability' of the effects on pain by comparing the MRI data at the end of all TMS visits between and within groups with factor analysis.
The relative efficacy of these strategies will directly translate to development of a large clinical trial investigating rTMS as an innovative, new treatment option for pain in patients with CLBP.
- Conditions
- Chronic Pain, Chronic Lower Back Pain, Back Pain, Opioid Use, Opiate Dependence, Pain, Chronic
- Being tested
- Real TBS to the mPFC, Sham TBS to the mPFC, Real TBS to the MC, Sham TBS to the MC
- Keywords
- Transcranial Magnetic Stimulation, Brain Stimulation, Treatment, Neuroimaging, Alternative
- Medical subject headings
- Chronic Pain, Back Pain, Opioid-Related Disorders, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real TBS to the mPFCDevice
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded)
Sham TBS to the mPFCDevice
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.
Real TBS to the MCDevice
This will be delivered with the Magventure Magpro system (double blinded).
Sham TBS to the MCDevice
This will be delivered with the Magventure Magpro system (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.
| Study group | Role | What they receive |
|---|---|---|
| Real TBS to the mPFC | Experimental | Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Receives: Device: Real TBS to the mPFC |
| Sham TBS to the mPFC | Sham comparator | Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Receives: Device: Sham TBS to the mPFC |
| Real TBS to the MC | Experimental | Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Receives: Device: Real TBS to the MC |
| Sham TBS to the MC | Sham comparator | Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Receives: Device: Sham TBS to the MC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Patient Reported Pain and Discomfort
The investigators expect changes in self reported qualitative 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. Percent change from baseline values ranged from -100 to 500. Larger, positive values represent increased pain and worse outcomes.
Measured: From Baseline to the last follow up session (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start15 Jun 2020
- Primary completion6 Jul 2022
- Study completion6 Jul 2022
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
- Phase N/A
- 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 MC (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 Wake Forest University clinics and the outer community 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 TMS to the MC, MPFC,or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected. Quantitative Pain Testing will be collected 11 times. MRI data will be collected 3 times: before the 1st visit of TMS, after the 12th visit of TMS, and after the 16th visit of TMS.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merideth A Addicott, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156802
- Sponsor's protocol ID
- IRB00061967
- Status last verified
- May 2023
- First submitted
- 4 Nov 2019
- Last updated
- 12 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared. All data is de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Relief: Developing Brain Stimulation as a Treatment for Chronic Pain
- ClinicalTrials.gov ID
- NCT04156802
- Acronym / sponsor ID
- IRB00061967
- Conditions
- Chronic Pain, Chronic Lower Back Pain, Back Pain, Opioid Use, Opiate Dependence, Pain, Chronic
- Keywords
- Transcranial Magnetic Stimulation, Brain Stimulation, Treatment, Neuroimaging, Alternative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Posted 12 May 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 largely treated with opiate narcotics, much as was done in the Civil War. In addition to their 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.
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 Repetitive transcranial magnetic stimulation (rTMS) to the primary motor cortex (MC) or the medial prefrontal cortex (MPFC) 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 Wake Forest Baptist Health (WFBH) clinics with chronic lower back pain that have not been able to find adequate pain relief, whether or not they are using prescription opiates for 3 or more months. Participants will be randomized to receive rTMS to the MC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity 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).
Detailed description
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 largely treated with opiate narcotics, much as was done in the Civil War. In addition to their 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.
The goal of this proposal is to evaluate 2 novel non-invasive brain stimulation strategies to mitigate pain and the brain's response to pain in CLBP patients that are currently taking chronic opiates, or that are seeking an alternative treatment for pain. 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. Our group has 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 our understanding of functional neural architecture, wherein the SN is modulated by 2 other core networks: the executive control network (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 MC or the MPFC 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 WFBH clinics with chronic lower back pain that have not been able to find adequate pain relief, whether or not they are using prescription opiates for 3 or more months. Participants will be randomized to receive rTMS to the MC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity 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).
Aim 1. Evaluate MC rTMS as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: MC TMS will attenuate the baseline brain response to pain (Pain Network activity) and increase activity in the ECN when the patient is given instructions to 'control' the pain.
Aim 2. Evaluate 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 SN when the patient is given instructions to 'control' the pain.
(Exploratory Aim): The investigator will evaluate if there are rate-dependent effects between baseline SN connectivity with the ECN and DMN and the efficacy of each TMS strategy on subjective pain. Data will be analyzed by using multivariate pattern analysis (MVPA). While the primary outcomes will be magnetic resonance imaging (MRI) Visit 1 versus Visit 2, the investigator will also examine the relative 'durability' of the effects on pain by comparing the MRI data at the end of all TMS visits between and within groups with factor analysis.
The relative efficacy of these strategies will directly translate to development of a large clinical trial investigating rTMS as an innovative, new treatment option for pain in patients with CLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- 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 MC (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 Wake Forest University clinics and the outer community 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 TMS to the MC, MPFC,or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected. Quantitative Pain Testing will be collected 11 times. MRI data will be collected 3 times: before the 1st visit of TMS, after the 12th visit of TMS, and after the 16th visit of TMS.
| Arm | Type | Receives |
|---|---|---|
| Real TBS to the mPFC | Experimental | Device: Real TBS to the mPFCTwo sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study |
| Sham TBS to the mPFC | Sham comparator | Device: Sham TBS to the mPFCTwo sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study |
| Real TBS to the MC | Experimental | Device: Real TBS to the MCTwo sessions of real Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study |
| Sham TBS to the MC | Sham comparator | Device: Sham TBS to the MCTwo sessions of sham Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study |
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 18-75 (to maximize participation)
- Can currently be 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.
- Meets DSM V criteria for current axis I disorders of obsessive-compulsive disorder, 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.
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 TBS to the mPFCThis will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded) | Device | Real TBS to the mPFC |
| Sham TBS to the mPFCThis will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil. | Device | Sham TBS to the mPFC |
| Real TBS to the MCThis will be delivered with the Magventure Magpro system (double blinded). | Device | Real TBS to the MC |
| Sham TBS to the MCThis will be delivered with the Magventure Magpro system (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil. | Device | Sham TBS to the MC |
Primary outcome
Changes in Patient Reported Pain and Discomfort
Time frame: From Baseline to the last follow up session (16 weeks)
The investigators expect changes in self reported qualitative 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. Percent change from baseline values ranged from -100 to 500. Larger, positive values represent increased pain and worse outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be shared. All data is de-identified.
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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.
Merideth A Addicott, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real TBS to the mPFC and Real TBS to the MC in people with Chronic Pain and Chronic Lower Back Pain, run by Wake Forest University Health Sciences 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 12 May 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 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?
Changes in Patient Reported Pain and Discomfort (time frame: From Baseline to the last follow up session (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 12 May 2023.