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Completed

NCT Number: NCT03243084

Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Chronic Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

XCSITE100 Stimulator Sham

Device

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

XCSITE100 Stimulator tACS

Device

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: BPS

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 8, 2017
Registry last updated
Dec 12, 2018

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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