TMS for CRPS - Pilot Study

Not Applicable

Completed

• Conditions: Complex Regional Pain Syndrome (CRPS)
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT01926119
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS) may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS in a small pilot study to investigate what methods may have clinical potential. This is a small pilot study to determine feasibility and signal to potentially inform future trials.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-11-17
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-30
• Last Update Submitted: 2017-03-30
• Results First Posted: 2017-05-10
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Age 18 or older
2. Diagnosis of CRPS (complex regional pain syndrome)
3. Average pain level reported on Numerical Rating Scale meets entry criteria
4. Ability to perform the experimental task and procedures.

Read More

Exclusion Criteria

1. MRI contraindication (metal implants or devices, claustrophobia)
2. TMS Contraindication (eg metal implant or devices near the site of stimulation)
3. History of epilepsy
4. History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
5. Neurologic illness that would interfere with brain integrity
6. Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
7. Currently pregnant or planning to become pregnant.
8. On going legal action or disability claim.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TMS Intervention - 5 days	Transcranial Magnetic Stimulation	Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.

Primary Outcome Measures

Name	Time	Method
Change in Pain	Baseline to post-TMS day 5	Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Change in Sudomotor Function	End of each treatment session and at 1-week follow-up as compared to baseline
Change in Vasomotor Function	End of each treatment session and at 1-week follow-up as compared to baseline
Change in Sensory Perception	End of each treatment session and at 1-week follow-up as compared to baseline
Trophic Changes	End of each treatment session and at 1-week follow-up as compared to baseline
Change in Motor Function and Coordination	End of 5-day treatment series and at 1-week follow-up relative to baseline	As assessed by functional capacity exam and physical exam
Change in Motor Strength and Joint Range of Motion	End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States