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Completed

NCT Number: NCT01926119

TMS for CRPS - Pilot Study

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.

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Key information

Conditions

Complex Regional Pain Syndrome (CRPS) Autonomic Nervous System Diseases Complex Regional Pain Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Primary outcomes

  1. Change in Pain

    Time frame: Baseline to post-TMS day 5

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

Secondary outcomes

  1. Change in Motor Function and Coordination

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

    As assessed by functional capacity exam and physical exam

  2. Change in Sensory Perception

    Time frame: End of each treatment session and at 1-week follow-up as compared to baseline

  3. Change in Vasomotor Function

    Time frame: End of each treatment session and at 1-week follow-up as compared to baseline

  4. Change in Sudomotor Function

    Time frame: End of each treatment session and at 1-week follow-up as compared to baseline

  5. Trophic Changes

    Time frame: End of each treatment session and at 1-week follow-up as compared to baseline

  6. Change in Motor Strength and Joint Range of Motion

    Time frame: End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 20, 2013
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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