Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy (BPS)

November 16, 2018 updated by: University of North Carolina, Chapel Hill

Effect of Transcranial Alternating Current Stimulation in Chronic Low Back Pain: A Pilot Study

Chronic pain is a severe disabling problem within society, affecting 25-30% of the United States population.. Transcranial alternating current stimulation (tACS) has the potential to provide a treatment option that is safe, scientifically-supported, low-cost, and easy-to-administer method to effectively reduce symptoms in patients suffering from chronic pain. The purpose of this study is to test the feasibility of using tACS to treat patients with chronic pain, and to collect pilot efficacy as well as EEG and EKG biomarker data for optimizing the design of subsequent large-scale studies. The treatment rationale is to renormalize the presumed pathological structure of alpha oscillations in the prefrontal cortex (PFC) of patients with chronic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged 18-65
  • Diagnosed with nonspecific chronic low back pain by clinician
  • BMI is less than 30
  • Suffered from chronic pain for > 6 months
  • Self-report pain measures >4
  • Meets criteria for low depression and suicide risk as defined by the Hamilton-Depression Rating Scale
  • Capacity to understand all relevant risks and potential benefits of the study (informed consent)
  • Not currently taking opioids, benzodiazepines, and anticonvulsant medications

Exclusion Criteria:

  • Radicular Pain
  • Traumatic brain injury, Any brain devices/implants, including cochlear implants and aneurysm clips
  • History of major neurological or psychiatric illness, including epilepsy
  • (For females) Pregnancy or breast feeding
  • Diagnosis of eating disorder (current or within the past 6 months), Obsessive Compulsive Disorder (lifetime), or Attention-Deficit Hyperactivity Disorder (currently under treatment)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham tACS
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
Device: XCSITE100 Stimulator Sham
The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session
Other Names:
  • Sham tACS
Active Comparator: Active 10 Hz tACS
Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
Device: XCSITE100 Stimulator tACS
Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied
Other Names:
  • tACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability Before and After 40-minute Stimulation
Time Frame: before and after 40-minute stimulation at each session
Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation
before and after 40-minute stimulation at each session
Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation
Time Frame: 5 minute recordings before and after each 40-minute stimulation at each session.
Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation
5 minute recordings before and after each 40-minute stimulation at each session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation
Time Frame: before and after 40 minute stimulation session
Self reported pain rating using a Visual Analog Scale (VAS) ranging from 0-10 done before and after stimulation with '0' being no pain and '10' as bad as it could be. Lower values represent a better outcome. (Pain difference was normalized using modulation index to account for ordinal scale)
before and after 40 minute stimulation session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Karen McCulloch, PhD, DPT, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

January 10, 2018

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-0870
  • R01MH101547 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No Plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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