TMS for Complex Regional Pain Syndrome
ConditionComplex Regional Pain Syndromes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial Magnetic Stimulation (TMS)
DeviceThe Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active TreatmentExperimental treatment 1 intervention
Group B: Sham TreatmentSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain
Decrease in CRPS-related Pain Ratings
Time frame
1 week follow-up compared to baseline2
Duration of Pain Relief
Duration of decreased CRPS-related pain ratings, measured as a length of time until pain returns for two consecutive weeks
Time frame
Duration from last treatment until pain returns - up to an estimate of 6 monthsSecondary outcomes
1
Change in Pain-related Symptomology
Decreases in Pain-related Symptomology (i.e., cognitive, emotional and physical)
Time frame
Duration from last treatment until pain returns - up to an estimate of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Redlich Pain Endowment
Collaborator
Rocky Mountain Foundation
Collaborator
The Feldman Family Foundation Pain Research Fund
Collaborator
Source ClinicalTrials.gov