TMS for CRPS - Pilot Study

NCT01926119 | Completed Results

• 1 other identifier: 25894
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndrome (CRPS)

Outcome Measures

Primary Outcomes (1)

• Change in Pain

  Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable

  Baseline to post-TMS day 5

Secondary Outcomes (6)

• Change in Motor Function and Coordination

  End of 5-day treatment series and at 1-week follow-up relative to baseline

• Change in Sensory Perception

  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 Sudomotor Function

  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

Study Arms (1)

TMS Intervention - 5 days

EXPERIMENTAL

Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

TMS Intervention - 5 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Diagnosis of CRPS (complex regional pain syndrome)
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Kevin Johnson, PhD RN
• Organization: Stanford University

johnsk@stanford.edu

(650) 721-1988

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Pain Medicine

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 20, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 10, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-03

Locations

US (1)