Complex Regional Pain SyndromesNCT03137472
TMS for Complex Regional Pain Syndrome
A study testing Transcranial Magnetic Stimulation (TMS) in people with Complex Regional Pain Syndromes, run by Stanford University at 1 site in United States.
Trial summary
The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2017to 29 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Diagnosis of CRPS (complex regional pain syndrome) for at least 3 months
- Average pain level reported on Numerical Rating Scale meets entry criteria
- Ability to perform the experimental task and procedures.
Who cannot join
- MRI contraindication (metal implants or devices, claustrophobia)
- TMS Contraindication (eg metal implant or devices near the site of stimulation)
- History of epilepsy
- History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
- Neurologic illness that would interfere with brain integrity
- Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
- Currently pregnant or planning to become pregnant.
- On going legal action or disability claim.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Pain Management Center
Redwood City, California, 94043
Birute Gedrimaite, 650-497-0485, birute@stanford.edu
About this study
Official title: Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS)
The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. Participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- TMS, CRPS, Sham
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Participants will receive active TMS in the target area once daily for two days Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| Sham Treatment | Sham comparator | Participants will receive active TMS in a non-target area once daily for two days Receives: Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Decrease in CRPS-related Pain Ratings
Measured: 1 week follow-up compared to baseline
Duration of Pain Relief
Duration of decreased CRPS-related pain ratings, measured as a length of time until pain returns for two consecutive weeks
Measured: Duration from last treatment until pain returns - up to an estimate of 6 months
Secondary outcomes (1)
Change in Pain-related Symptomology
Decreases in Pain-related Symptomology (i.e., cognitive, emotional and physical)
Measured: Duration from last treatment until pain returns - up to an estimate of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start24 Apr 2017
- Primary completion29 Jun 2028 (estimated)
- Study completion29 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Redlich Pain Endowment, Rocky Mountain Foundation, The Feldman Family Foundation Pain Research Fund
- Responsible party
- Principal investigator, Sean Mackey, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137472
- Sponsor's protocol ID
- 25894-3
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2017
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS)
- ClinicalTrials.gov ID
- NCT03137472
- Acronym / sponsor ID
- 25894-3
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- TMS, CRPS, Sham
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Redlich Pain Endowment, Rocky Mountain Foundation, The Feldman Family Foundation Pain Research Fund
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 29 Jun 2028 (estimated)
- Study completion
- 29 Jun 2028 (estimated)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. Participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Device: Transcranial Magnetic Stimulation (TMS)Participants will receive active TMS in the target area once daily for two days |
| Sham Treatment | Sham comparator | Device: Transcranial Magnetic Stimulation (TMS)Participants will receive active TMS in a non-target area once daily for two days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70
- Diagnosis of CRPS (complex regional pain syndrome) for at least 3 months
- Average pain level reported on Numerical Rating Scale meets entry criteria
- Ability to perform the experimental task and procedures.
Key exclusion criteria (8 listed)
- MRI contraindication (metal implants or devices, claustrophobia)
- TMS Contraindication (eg metal implant or devices near the site of stimulation)
- History of epilepsy
- History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
- Neurologic illness that would interfere with brain integrity
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS). | Device | Active Treatment, Sham Treatment |
Primary outcome
Change in Pain
Time frame: 1 week follow-up compared to baseline
Decrease in CRPS-related Pain Ratings
Duration of Pain Relief
Time frame: Duration from last treatment until pain returns - up to an estimate of 6 months
Duration of decreased CRPS-related pain ratings, measured as a length of time until pain returns for two consecutive weeks
1 secondary outcome
Change in Pain-related Symptomology
Time frame: Duration from last treatment until pain returns - up to an estimate of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Complex Regional Pain Syndromes, run by Stanford University 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 4 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Altirkawi ((650) 497-0485, omar97@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: 1 week follow-up compared to baseline). 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?
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 23 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.