Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

NCT03243084 | Completed Results FDA Device

• 2 other identifiers: 17-0870R01MH101547
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tACS; transcranial alternating current stimulation; low back pain; chronic pain; alpha oscillations; heart rate variability

Outcome Measures

Primary Outcomes (2)

• Change in Heart Rate Variability Before and After 40-minute Stimulation

  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

  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 Outcomes (1)

• Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation

  before and after 40 minute stimulation session

Study Arms (2)

Sham tACS

SHAM COMPARATOR

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

Active 10 Hz tACS

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Sham tACS

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

Also known as: tACS

Active 10 Hz tACS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (2)

• Prim JH, Ahn S, Davila MI, Alexander ML, McCulloch KL, Frohlich F. Targeting the Autonomic Nervous System Balance in Patients with Chronic Low Back Pain Using Transcranial Alternating Current Stimulation: A Randomized, Crossover, Double-Blind, Placebo-Controlled Pilot Study. J Pain Res. 2019 Dec 11;12:3265-3277. doi: 10.2147/JPR.S208030. eCollection 2019.

  PMID: 31849514 DERIVED

• Ahn S, Prim JH, Alexander ML, McCulloch KL, Frohlich F. Identifying and Engaging Neuronal Oscillations by Transcranial Alternating Current Stimulation in Patients With Chronic Low Back Pain: A Randomized, Crossover, Double-Blind, Sham-Controlled Pilot Study. J Pain. 2019 Mar;20(3):277.e1-277.e11. doi: 10.1016/j.jpain.2018.09.004. Epub 2018 Sep 27.

  PMID: 30268803 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations of the study include small sample size. Participants received only 1 session of Active 10 Hz tACS by design but there is likely an additive effect and future studies should investigate multiple sessions.

Results Point of Contact

• Title: Julianna Prim
• Organization: UNC Chapel Hill

jhprim@email.unc.edu

919-962-5271

Study Officials

• Karen McCulloch, PhD, DPT

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for creating the stimulation codes that run each session and for ensuring that these codes worked correctly.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will receive sham stimulation and 10Hz tACS stimulation at two separate sessions. The order will be randomized (ie, half the participants will receive sham stimulation at the first session and 10Hz tACS stimulation at the second session, and the other half will receive 10Hz tACS stimulation at the first session and sham stimulation at the second session).

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 8, 2017
• Study Start: September 7, 2017
• Primary Completion: December 31, 2017
• Study Completion: January 10, 2018
• Last Updated: December 12, 2018
• Results First Posted: December 12, 2018

Record last verified: 2018-01

Locations

US (1)