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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XCSITE100 Stimulator Sham
XCSITE100 Stimulator tACS
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Low Back Pain focused on measuring tACS, transcranial alternating current stimulation, low back pain, chronic pain, alpha oscillations, heart rate variability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of North Carolina Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham tACS

Active 10 Hz tACS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
August 3, 2017
Last Updated
November 16, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03243084
Brief Title
Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy
Acronym
BPS
Official Title
Effect of Transcranial Alternating Current Stimulation in Chronic Low Back Pain: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
tACS, transcranial alternating current stimulation, low back pain, chronic pain, alpha oscillations, heart rate variability

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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).
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham tACS
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Active 10 Hz tACS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
XCSITE100 Stimulator Sham
Other Intervention Name(s)
Sham tACS
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
XCSITE100 Stimulator tACS
Other Intervention Name(s)
tACS
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Heart Rate Variability Before and After 40-minute Stimulation
Description
Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation
Time Frame
before and after 40-minute stimulation at each session
Title
Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation
Description
Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation
Time Frame
5 minute recordings before and after each 40-minute stimulation at each session.
Secondary Outcome Measure Information:
Title
Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation
Description
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)
Time Frame
before and after 40 minute stimulation session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen McCulloch, PhD, DPT
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
No Plan
Citations:
PubMed Identifier
31849514
Citation
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.
Results Reference
derived
PubMed Identifier
30268803
Citation
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.
Results Reference
derived

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Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

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