TMS for CRPS - Pilot Study

Complex Regional Pain Syndrome (CRPS) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926119
• Other study ID #: 25894
• Status: Completed
• Phase: N/A
• First received: August 16, 2013
• Last updated: February 4, 2014
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome (CRPS)
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy

Intervention

Device:
• Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain		End of each of the 5 treatment sessions and at 1-week follow-up compared to baseline	No
Secondary	Change in motor function and coordination	As assessed by functional capacity exam and physical exam	End of 5-day treatment series and at 1-week follow-up relative to baseline	No
Secondary	Change in sensory perception		End of each treatment session and at 1-week follow-up as compared to baseline	No
Secondary	Change in vasomotor function		End of each treatment session and at 1-week follow-up as compared to baseline	No
Secondary	Change in sudomotor function		End of each treatment session and at 1-week follow-up as compared to baseline	No
Secondary	Trophic changes		End of each treatment session and at 1-week follow-up as compared to baseline	No
Secondary	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	No