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Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

NCT03243084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-12-12

Study results available
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Summary

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.

Conditions

  • Chronic Low Back Pain

Interventions

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

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Karen McCulloch, PhD, DPT · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-07
Primary Completion
2017-12-31
Completion
2018-01-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243084 on ClinicalTrials.gov