TMS for Complex Regional Pain Syndrome
Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS)
1 other identifier
interventional
40
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2017
CompletedFirst Submitted
Initial submission to the registry
April 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 29, 2026
May 13, 2025
May 1, 2025
9.2 years
April 28, 2017
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Pain
Decrease in CRPS-related Pain Ratings
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
Duration from last treatment until pain returns - up to an estimate of 6 months
Secondary Outcomes (1)
Change in Pain-related Symptomology
Duration from last treatment until pain returns - up to an estimate of 6 months
Study Arms (2)
Active Treatment
EXPERIMENTALParticipants will receive active TMS in the target area once daily for two days
Sham Treatment
SHAM COMPARATORParticipants will receive active TMS in a non-target area once daily for two days
Interventions
The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institutes of Health (NIH)collaborator
- Redlich Pain Endowmentcollaborator
- Rocky Mountain Foundationcollaborator
- The Feldman Family Foundation Pain Research Fundcollaborator
Study Sites (1)
Stanford Pain Management Center
Redwood City, California, 94043, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single, blinding of participant
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of Pain Medicine
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 2, 2017
Study Start
April 24, 2017
Primary Completion (Estimated)
June 29, 2026
Study Completion (Estimated)
June 29, 2026
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share