PainPhase 2/3NCT00349050
Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
A Phase 2/3 study testing laboratory pain assessment and transcranial magnetic stimulation in people with Pain and Trigeminal Neuralgia, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of transcranial magnetic stimulation on pain perception. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Trigeminal Neuralgia, Neuropathic Pain
- What is being tested?
- laboratory pain assessment and transcranial magnetic stimulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Oct 2010
- Phase
- Phase 2/3
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Healthy Adults:
- Between age of 21 and 60
- No prescription medications in previous 3 months
- No seizure history
- No depression
- Not suicidal
Show all 30Show fewer
- No anxiety
- No hospitalizations or surgeries in previous 6 months
- No history of chronic pain conditions
- No implanted metal devices (e.g., pacemakers, metal plates, wires)
- Not pregnant
- No alcohol abuse/dependence history in previous 6 months
- No illicit drug use in previous 6 months
- Capable of reading, writing, giving consent, following instructions
- No history of brain surgery or history of loss of consciousness >15 minutes
- No history of autoimmune or endocrine disorder
- No significant anxiety about entering MRI scanner
- For Patients with neuropathic pain:
- Between age of 21 and 75
- No seizure history
- Not taking medications shown to increase seizure risk (6 months)
- Not suicidal
- No hospitalizations or surgeries in previous 3 months
- No implanted metal devices (e.g., pacemakers, metal plates, wires)
- Not pregnant
- No alcohol abuse/dependence history in previous 6 months
- No illicit drug use in previous 6 months
- Capable of reading, writing, giving consent, following instructions
- Chronic pain (>6 months), not significantly relieved by pharmacological treatment
- No significant anxiety about entering MRI scanner
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina 5-North, IOP, 67 President Street
Charleston, South Carolina, 29425
About this study
The purpose of this study is to investigate the effects of transcranial magnetic stimulation on pain perception.
Read the detailed description
Chronic pain represents a huge public health concern and is generally poorly understood at a basic neurobiological level. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthesia, or other invasive procedures). Previous research suggests that TMS may be effective in reducing pain perception in healthy adults and in patients with various types of pain conditions, such as neuropathic pain. However, there is relatively little research on TMS and pain that addresses optimal TMS device parameters, optimal cortical targets, and potential differences in response to TMS between healthy persons and those with chronic pain.
The purpose of this trial is to study the effects of TMS on pain perception. Specifically, this study will determine optimal device parameters (dose) and brain targets for stimulation with TMS in order to reduce pain in patients with neuropathic pain and in healthy adults using laboratory pain methods.
Participants with Neuropathic Pain:
After an initial screening, eligible participants with neuropathic pain will receive a magnetic resonance imaging (MRI) scan to help determine the best target for TMS stimulation later in the study. Participants will be asked to record their pain experiences every day for 2-4 weeks before receiving the first of 2 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
The next part of the trial involves two, 20-minute TMS treatment sessions per day for 5-days. Participants will be randomly assigned to one of two groups. Group A will receive real TMS and Group B will receive "sham" TMS. Study participation time for individuals with TGN is about 8 weeks, including about 10 hours (7 visits) at the Medical University of South Carolina (MUSC).
Healthy Volunteers:
In addition to an interview with researchers regarding medical history, healthy participants will complete a self-report screening to assess pain history and level of depression and anxiety. Eligible participants will be given a laboratory pain assessment, and be randomly assigned to one of two groups: group A will receive real TMS and group B will receive "sham" TMS. After TMS, participants will receive another full laboratory pain assessment and complete questionnaires. For healthy volunteers, participation in the study will take about 3 hours and may be completed in one or two visits.
- Conditions
- Pain, Trigeminal Neuralgia, Neuropathic Pain
- Being tested
- laboratory pain assessment, transcranial magnetic stimulation
- Keywords
- trigeminal neuralgia, neuropathic pain, complex regional pain syndrome, reflex sympathetic dystrophy, pain, chronic pain, transcranial magnetic stimulation, TMS, laboratory pain assessment
- Medical subject headings
- Pain, Trigeminal Neuralgia, Neuralgia, Complex Regional Pain Syndromes, Reflex Sympathetic Dystrophy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory pain assessmentDevice
Participants will record their pain experiences every day for 2 weeks before receiving the first of 5 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
transcranial magnetic stimulationProcedure or surgery
There will be two, 20-minute, 3-day TMS treatment sessions. Participants will be randomly assigned to one of two groups. Group A will receive real TMS for the first 3-day treatment and "sham" TMS (which does not involve real stimulation) for the second treatment. Group B will receive "sham" TMS for the first treatment, and real TMS for the second treatment. Regardless of the group, participants will receive both real and "sham" TMS.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | laboratory pain assessment Receives: Device: laboratory pain assessment |
| 2 | Active comparator | transcranial magnetic stimulation Receives: Procedure: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).
Measured: measured during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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, Ph.D., Principal investigator, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349050
- Sponsor's protocol ID
- K23NS050485-01A2
- Other IDs
- K23NS050485-01A2
- Status last verified
- Oct 2010
- First submitted
- 5 Jul 2006
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
- ClinicalTrials.gov ID
- NCT00349050
- Acronym / sponsor ID
- K23NS050485-01A2
- Conditions
- Pain, Trigeminal Neuralgia, Neuropathic Pain
- Keywords
- trigeminal neuralgia, neuropathic pain, complex regional pain syndrome, reflex sympathetic dystrophy, pain, chronic pain, transcranial magnetic stimulation, TMS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Jul 2006 (estimated)
- 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 investigate the effects of transcranial magnetic stimulation on pain perception.
Detailed description
Chronic pain represents a huge public health concern and is generally poorly understood at a basic neurobiological level. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthesia, or other invasive procedures). Previous research suggests that TMS may be effective in reducing pain perception in healthy adults and in patients with various types of pain conditions, such as neuropathic pain. However, there is relatively little research on TMS and pain that addresses optimal TMS device parameters, optimal cortical targets, and potential differences in response to TMS between healthy persons and those with chronic pain.
The purpose of this trial is to study the effects of TMS on pain perception. Specifically, this study will determine optimal device parameters (dose) and brain targets for stimulation with TMS in order to reduce pain in patients with neuropathic pain and in healthy adults using laboratory pain methods.
Participants with Neuropathic Pain:
After an initial screening, eligible participants with neuropathic pain will receive a magnetic resonance imaging (MRI) scan to help determine the best target for TMS stimulation later in the study. Participants will be asked to record their pain experiences every day for 2-4 weeks before receiving the first of 2 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
The next part of the trial involves two, 20-minute TMS treatment sessions per day for 5-days. Participants will be randomly assigned to one of two groups. Group A will receive real TMS and Group B will receive "sham" TMS. Study participation time for individuals with TGN is about 8 weeks, including about 10 hours (7 visits) at the Medical University of South Carolina (MUSC).
Healthy Volunteers:
In addition to an interview with researchers regarding medical history, healthy participants will complete a self-report screening to assess pain history and level of depression and anxiety. Eligible participants will be given a laboratory pain assessment, and be randomly assigned to one of two groups: group A will receive real TMS and group B will receive "sham" TMS. After TMS, participants will receive another full laboratory pain assessment and complete questionnaires. For healthy volunteers, participation in the study will take about 3 hours and may be completed in one or two visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: laboratory pain assessmentlaboratory pain assessment |
| 2 | Active comparator | Procedure: transcranial magnetic stimulationtranscranial magnetic stimulation |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (30 listed)
- Between age of 21 and 60
- No prescription medications in previous 3 months
- No seizure history
- No depression
- Not suicidal
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| laboratory pain assessmentParticipants will record their pain experiences every day for 2 weeks before receiving the first of 5 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort. | Device | 1 |
| transcranial magnetic stimulationThere will be two, 20-minute, 3-day TMS treatment sessions. Participants will be randomly assigned to one of two groups. Group A will receive real TMS for the first 3-day treatment and "sham" TMS (which does not involve real stimulation) for the second treatment. Group B will receive "sham" TMS for the first treatment, and real TMS for the second treatment. Regardless of the group, participants will receive both real and "sham" TMS. | Procedure or surgery | 2 |
Primary outcome
Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).
Time frame: measured during the study period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
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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, Ph.D. principal investigator
Department of Psychiatry and Behavioral Sciences, 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 2/3 study testing laboratory pain assessment and transcranial magnetic stimulation in people with Pain and Trigeminal Neuralgia, 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 30 inclusion and 0 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: withdrawn, as of the sponsor's last update on 30 Apr 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings). (time frame: measured during the study period). 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 30 Apr 2012.