NCT02070016

Brief Summary

The purpose of this study is to test whether non-invasive brain stimulation, such as Transcranial Magnetic Stimulation (TMS) may alleviate pain associated with various chronic pain conditions. We will test various methods of TMS to identify a treatment approach that may reduce the symptoms of chronic pain for the patient.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

February 4, 2014

Last Update Submit

August 5, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Average Daily Pain

    Compared to baseline pain report as provided by Visual Analogue Scale (VAS)

    Baseline Compared to each treatmeant series (at 4 weeks, 8 weeks, and 12 weeks)

  • Change in Worst Daily Pain

    As compared to baseline worst daily pain report provided on visual analogue scale (VAS)

    Baseline Compared to each treatment series (at 4 weeks, 8 weeks, and 12 weeks)

Study Arms (2)

TMS Parameter Condition 1 first

EXPERIMENTAL

Application of Transcranial Magnetic Stimulation

Device: Transcranial Magnetic Stimulation

TMS Parameter Condition 2 First

EXPERIMENTAL

Application of Transcranial Magnetic Stimulation

Device: Transcranial Magnetic Stimulation

Interventions

TMS Parameter Condition 1 firstTMS Parameter Condition 2 First

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Patient with Chronic Low Back Pain
  • Meets minimum pain level criteria
  • Ability to perform the experimental Task and Procedures

You may not qualify if:

  • MRI contraindication if an MRI exam is required per protocol
  • TMS Contraindication
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Pain Medicine

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 24, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations