TMS for Complex Regional Pain Syndrome

Complex Regional Pain Syndromes Clinical Trial

Official title:

Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03137472
• Other study ID #: 25894-3
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: June 29, 2024

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Birute Gedrimaite
• Phone: (650) 497-0485
• Email: birute[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Device:
• Transcranial Magnetic Stimulation (TMS)
The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).

Locations

Country	Name	City	State
United States	Stanford Pain Management Center	Redwood City	California

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH), Redlich Pain Endowment, Rocky Mountain Foundation, The Feldman Family Foundation Pain Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain	Decrease in CRPS-related Pain Ratings	1 week follow-up compared to baseline
Primary	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	Change in Pain-related Symptomology	Decreases in Pain-related Symptomology (i.e., cognitive, emotional and physical)	Duration from last treatment until pain returns - up to an estimate of 6 months