Chronic PainNCT01030133
Effects of Transcranial Magnetic Stimulation (TMS) and Stimulus Controllability on Pain Perception
A study testing Operator Role Real TMS, Receiver Role Real TMS and All Participants Operator Role in people with Chronic Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Although transcranial magnetic stimulation (TMS) is now considered a minimal risk intervention, is approved for the treatment of depression, and is widely used around the world, little is known about mechanisms of action of prefrontal rTMS for depression or pain. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Operator Role Real TMS, Receiver Role Real TMS and All Participants Operator Role
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Feb 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years of age
Who cannot join
- history of seizures or epilepsy
- family history of seizures
- history of chronic pain conditions
- current depression
- anxiety disorders
- taking any medications shown to lower seizure threshold
Show all 10Show fewer
- metal implants above the waist
- pregnant
- brain tumors or lesions
- pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Brain Stimulation Laboratory, Institute of Psychiatry
Charleston, South Carolina, 29425
About this study
Official title: Effects of TMS and Stimulus Controllability on Pain Perception
Although transcranial magnetic stimulation (TMS) is now considered a minimal risk intervention, is approved for the treatment of depression, and is widely used around the world, little is known about mechanisms of action of prefrontal rTMS for depression or pain. There is some evidence that the prefrontal cortex is involved in perception of control and may moderate the effects of perceived controllability on emotional reactivity to painful stimuli. The present study aims to investigate the effects of prefrontal rTMS and perceived controllability on pain perception in healthy adults.
Read the detailed description
Transcranial magnetic stimulation (TMS) is a minimally invasive brain stimulation technology that can focally stimulate the brain of an awake individual.1,2 A localized pulsed magnetic field transmitted through a figure-8 coil (lasting only microseconds) is able to focally stimulate the cortex by depolarizing superficial neurons3,4 which induces electrical currents in the brain.5 If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
rTMS over the prefrontal cortex has been shown to produce temporary analgesic effects in healthy adults using laboratory pain methods and in patients with chronic pain of various etiologies. However, little is known about mechanisms of action.
Evidence from functional MRI studies suggests that participants' perceived controllability over pain stimuli is associated with decreased pain experience and decreased activation of cortical and subcortical areas involved with pain perception.6 Perceived controllability may involved prefrontal cortical circuits and may be involved in inhibition of limbic system responses to painful stimuli.
To date, no studies have investigated the interaction between prefrontal TMS and perceived controllability on pain perception in healthy adults. Building on extensive pilot work and experience in the area of laboratory pain assessment and TMS in the Brain Stimulation Laboratory at MUSC, the investigators propose to investigate the effects of perceived controllability and prefrontal TMS on pain perception in healthy adults. This study may help determine whether TMS can be used to stimulate a cortical area thought to be involved in perceived controllability, thus enhancing one's sense of controllability and thereby substantially reduce pain intensity and unpleasantness.
Although transcranial magnetic stimulation (TMS) is now considered a minimal risk intervention, is approved for the treatment of depression, and is widely used around the world, little is known about mechanisms of action of prefrontal rTMS for depression or pain. There is some evidence that the prefrontal cortex is involved in perception of control and may moderate the effects of perceived controllability on emotional reactivity to painful stimuli. The present study aims to investigate the effects of prefrontal rTMS and perceived controllability on pain perception in healthy adults.
- Conditions
- Chronic Pain
- Being tested
- Operator Role Real TMS, Receiver Role Real TMS, Operator Role Sham TMS, Receiver Role Sham TMS, All Participants Operator Role
- Keywords
- Pain
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operator Role Real TMSDevice
In two of the four visits, the participant will be assigned to the operator condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice.
Receiver Role Real TMSDevice
In two of the four visits, the participant will be assigned to the receiver condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "receiver's" performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice.
Operator Role Sham TMSDevice
In two of the four visits, the participant will be assigned to the operator condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice.
Receiver Role Sham TMSDevice
In two of the four visits, the participant will be assigned to the receiver condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "receiver's" performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice.
All Participants Operator RoleDevice
All participants in Operator Role (Receiving real or sham TMS)
| Study group | Role | What they receive |
|---|---|---|
| Real TMS | Active comparator | Participants in the real Transcranial Magnetic Stimulation (TMS) group will receive real stimulation across all interventions; the operator role Real TMS and receiver role Real TMS. rTMS will be used to stimulate the left prefrontal cortex using two Neuronetics TMS machines with figure-8, iron core coils at 10Hz and at 110% of resting motor threshold [5 second trains following each trial (25 trials per visit)]. Receives: Device: Operator Role Real TMS; Device: Receiver Role Real TMS |
| Sham TMS | Sham comparator | Participants in the sham Transcranial Magnetic Stimulation (TMS) group will receive sham stimulation across all interventions; the operator role Sham TMS and receiver role Sham TMS. Sham Stimulation involves 5 second trains of 10Hz rTMS in pairs alternating between real TMS and eSham TMS (randomly ordered). All sham treatment will be delivered with a specially designed, manufacture-provided sham TMS coil that looks and sounds identical to a real TMS coil but no magnetic current is transferred to the participant. Receives: Device: Operator Role Sham TMS; Device: Receiver Role Sham TMS |
| All Participants Operator Role | Other | All participants in Operator Role (Receiving real or sham TMS) Receives: Device: Operator Role Real TMS; Device: Operator Role Sham TMS; Device: All Participants Operator Role |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Unpleasantness During Perceived Control Condition
The perceived control condtion of the pain task consisted of 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS). The entire pain task (perceived control condition and no control condition) consisted of 60 trials. Participants in the operator role group rated the unpleasantness of each thermal stimulus on a computerized visual analog scale (VAS). Unpleasantness ratings are on a scale of 0 to 100. 0=not unpleasant. 100=extremely unpleasant. The ratings were averaged over all trials for the perceived control condition for the Real TMS and Sham TMS group. The results below, report the mean unpleasantness rating for both groups during the perceived control condition.
Measured: 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS
Pain Intensity During Perceived Control Condition
The perceived control condtion of the pain task consisted of 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS). The entire pain task (perceived control condition and no control condition) consisted of 60 trials.), participants in the operator role group rated the pain intensity of each thermal stimulus on a computerized visual analog scale (VAS). Pain intensity ratings are on a scale of 0 to 100. 0=not painful. 100=extremely painful. The ratings were averaged over all trials for the perceived control condition for the Real TMS and Sham TMS group. The results below, report the mean pain intensity rating for both groups during the perceived control condition.
Measured: 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS
Secondary outcomes (2)
Number of Participants That Correctly Guessed Their TMS Condition Assignment
After each participant completed the experiment, they guessed their TMS Condition, whether they received real or sham TMS.
Results below report the number of participants in each group that guessed their TMS condition correctly.
Measured: After Pain Control Paradigm
Confidence Ratings of Guessing TMS Condition Assignment
After participants guessed their TMS condition; whether they received real or sham TMS, They were then asked to rate the confidence in their guess. Ratings were on a scale of 0-10 where 0=complete guess and 10=absolutely sure.
Results below include the mean confidence ratings of those that guessed the TMS condition correctly and those that guessed incorrectly.
Measured: After Pain Control Paradigm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionFeb 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey J Borckardt, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030133
- Sponsor's protocol ID
- Borckardt_19079
- Status last verified
- Aug 2018
- First submitted
- 9 Dec 2009
- Last updated
- 28 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Borckardt JJ, Reeves ST, Frohman H, Madan A, Jensen MP, Patterson D, Barth K, Smith RA, Gracely R, George MS. Fast left prefrontal rTMS acutely suppresses analgesic effects of perceived controllability on the emotional component of pain experience. Pain. 2011 Jan;152(1):182-187. doi: 10.1016/j.pain.2010.10.018. Epub 2010 Nov 30.
PubMed 21122992
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TMS and Stimulus Controllability on Pain Perception
- ClinicalTrials.gov ID
- NCT01030133
- Acronym / sponsor ID
- Borckardt_19079
- Conditions
- Chronic Pain
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Posted 28 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although transcranial magnetic stimulation (TMS) is now considered a minimal risk intervention, is approved for the treatment of depression, and is widely used around the world, little is known about mechanisms of action of prefrontal rTMS for depression or pain. There is some evidence that the prefrontal cortex is involved in perception of control and may moderate the effects of perceived controllability on emotional reactivity to painful stimuli. The present study aims to investigate the effects of prefrontal rTMS and perceived controllability on pain perception in healthy adults.
Detailed description
Transcranial magnetic stimulation (TMS) is a minimally invasive brain stimulation technology that can focally stimulate the brain of an awake individual.1,2 A localized pulsed magnetic field transmitted through a figure-8 coil (lasting only microseconds) is able to focally stimulate the cortex by depolarizing superficial neurons3,4 which induces electrical currents in the brain.5 If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
rTMS over the prefrontal cortex has been shown to produce temporary analgesic effects in healthy adults using laboratory pain methods and in patients with chronic pain of various etiologies. However, little is known about mechanisms of action.
Evidence from functional MRI studies suggests that participants' perceived controllability over pain stimuli is associated with decreased pain experience and decreased activation of cortical and subcortical areas involved with pain perception.6 Perceived controllability may involved prefrontal cortical circuits and may be involved in inhibition of limbic system responses to painful stimuli.
To date, no studies have investigated the interaction between prefrontal TMS and perceived controllability on pain perception in healthy adults. Building on extensive pilot work and experience in the area of laboratory pain assessment and TMS in the Brain Stimulation Laboratory at MUSC, the investigators propose to investigate the effects of perceived controllability and prefrontal TMS on pain perception in healthy adults. This study may help determine whether TMS can be used to stimulate a cortical area thought to be involved in perceived controllability, thus enhancing one's sense of controllability and thereby substantially reduce pain intensity and unpleasantness.
Although transcranial magnetic stimulation (TMS) is now considered a minimal risk intervention, is approved for the treatment of depression, and is widely used around the world, little is known about mechanisms of action of prefrontal rTMS for depression or pain. There is some evidence that the prefrontal cortex is involved in perception of control and may moderate the effects of perceived controllability on emotional reactivity to painful stimuli. The present study aims to investigate the effects of prefrontal rTMS and perceived controllability on pain perception in healthy adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real TMS | Active comparator | Device: Operator Role Real TMS, Device: Receiver Role Real TMSParticipants in the real Transcranial Magnetic Stimulation (TMS) group will receive real stimulation across all interventions; the operator role Real TMS and receiver role Real TMS. rTMS will be used to stimulate the left prefrontal cortex using two Neuronetics TMS machines with figure-8, iron core coils at 10Hz and at 110% of resting motor threshold [5 second trains following each trial (25 trials per visit)]. |
| Sham TMS | Sham comparator | Device: Operator Role Sham TMS, Device: Receiver Role Sham TMSParticipants in the sham Transcranial Magnetic Stimulation (TMS) group will receive sham stimulation across all interventions; the operator role Sham TMS and receiver role Sham TMS. Sham Stimulation involves 5 second trains of 10Hz rTMS in pairs alternating between real TMS and eSham TMS (randomly ordered). All sham treatment will be delivered with a specially designed, manufacture-provided sham TMS coil that looks and sounds identical to a real TMS coil but no magnetic current is transferred to the participant. |
| All Participants Operator Role | Other | Device: Operator Role Real TMS, Device: Operator Role Sham TMS, Device: All Participants Operator RoleAll participants in Operator Role (Receiving real or sham TMS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-75 years of age
Key exclusion criteria (10 listed)
- history of seizures or epilepsy
- family history of seizures
- history of chronic pain conditions
- current depression
- anxiety disorders
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 |
|---|---|---|
| Operator Role Real TMSIn two of the four visits, the participant will be assigned to the operator condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice. | Device | All Participants Operator Role, Real TMS |
| Receiver Role Real TMSIn two of the four visits, the participant will be assigned to the receiver condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "receiver's" performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice. | Device | Real TMS |
| Operator Role Sham TMSIn two of the four visits, the participant will be assigned to the operator condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice. | Device | All Participants Operator Role, Sham TMS |
| Receiver Role Sham TMSIn two of the four visits, the participant will be assigned to the receiver condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "receiver's" performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice. | Device | Sham TMS |
| All Participants Operator RoleAll participants in Operator Role (Receiving real or sham TMS) | Device | All Participants Operator Role |
Primary outcome
Pain Unpleasantness During Perceived Control Condition
Time frame: 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS
The perceived control condtion of the pain task consisted of 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS). The entire pain task (perceived control condition and no control condition) consisted of 60 trials. Participants in the operator role group rated the unpleasantness of each thermal stimulus on a computerized visual analog scale (VAS). Unpleasantness ratings are on a scale of 0 to 100. 0=not unpleasant. 100=extremely unpleasant. The ratings were averaged over all trials for the perceived control condition for the Real TMS and Sham TMS group. The results below, report the mean unpleasantness rating for both groups during the perceived control condition.
Pain Intensity During Perceived Control Condition
Time frame: 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS
The perceived control condtion of the pain task consisted of 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS). The entire pain task (perceived control condition and no control condition) consisted of 60 trials.), participants in the operator role group rated the pain intensity of each thermal stimulus on a computerized visual analog scale (VAS). Pain intensity ratings are on a scale of 0 to 100. 0=not painful. 100=extremely painful. The ratings were averaged over all trials for the perceived control condition for the Real TMS and Sham TMS group. The results below, report the mean pain intensity rating for both groups during the perceived control condition.
2 secondary outcomes
Number of Participants That Correctly Guessed Their TMS Condition Assignment
Time frame: After Pain Control Paradigm
Confidence Ratings of Guessing TMS Condition Assignment
Time frame: After Pain Control Paradigm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21122992Borckardt JJ, Reeves ST, Frohman H, Madan A, Jensen MP, Patterson D, Barth K, Smith RA, Gracely R, George MS. Fast left prefrontal rTMS acutely suppresses analgesic effects of perceived controllability on the emotional component of pain experience. Pain. 2011 Jan;152(1):182-187. doi: 10.1016/j.pain.2010.10.018. Epub 2010 Nov 30.
- Article titled Fast left prefrontal rTMS acutely suppresses analgesic effects of perceived controllability on the emotional component of pain experienceLink provided by the sponsor.
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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 J 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 study testing Operator Role Real TMS, Receiver Role Real TMS and All Participants Operator Role in people with Chronic Pain, 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 1 inclusion and 10 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 28 Sep 2018. 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 28 Sep 2018). 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?
Pain Unpleasantness During Perceived Control Condition (time frame: 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01030133, which also lists 1 linked publication.
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 28 Sep 2018.