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Recruiting NCT03137472

TMS for Complex Regional Pain Syndrome

No phase Interventional Complex Regional Pain Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Stimulation (TMS).
Who it may be relevant to
Registry conditions: Complex Regional Pain Syndromes. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Change in Pain [Time frame: 1 week follow-up compared to baseline]
  • Duration of Pain Relief [Time frame: Duration from last treatment until pain returns - up to an estimate of 6 months]
Secondary outcome measures (1)
  • Change in Pain-related Symptomology [Time frame: Duration from last treatment until pain returns - up to an estimate of 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford Pain Management Center — Redwood City

Identifiers

NCT: NCT03137472 · 25894-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗