Chronic Low Back PainBPSNCT03243084

Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

A study testing XCSITE100 Stimulator tACS in people with Chronic Low Back Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: XCSITE100 Stimulator tACS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 7 Sep 2017to 10 Jan 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

Official title: 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.

Conditions: Chronic Low Back Pain
Being tested: XCSITE100 Stimulator Sham, XCSITE100 Stimulator tACS
Keywords: tACS, transcranial alternating current stimulation, low back pain, chronic pain, alpha oscillations, heart rate variability
Medical subject headings: Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XCSITE100 Stimulator ShamDevice
Also called Sham tACS
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
XCSITE100 Stimulator tACSDevice
Also called 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

Study groups in NCT03243084
Study group	Role	What they receive
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. Receives: 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. Receives: Device: XCSITE100 Stimulator tACS

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
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)
Measured: before and after 40 minute stimulation session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Sep 201710 Jan 2018

First posted8 Aug 2017
Study start7 Sep 2017
Primary completion31 Dec 2017
Study completion10 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03243084
Sponsor's protocol ID: 17-0870
Other IDs: R01MH101547
Acronym: BPS
Status last verified: Jan 2018
First submitted: 3 Aug 2017
Last updated: 12 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided: No Plan

Publications

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.
PubMed 31849514
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.
PubMed 30268803

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Transcranial Alternating Current Stimulation in Chronic Low Back Pain: A Pilot Study
ClinicalTrials.gov ID: NCT03243084
Acronym / sponsor ID: BPS / 17-0870
Conditions: Chronic Low Back Pain
Keywords: tACS, transcranial alternating current stimulation, low back pain, chronic pain, alpha oscillations, heart rate variability
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 7 Sep 2017 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 10 Jan 2018 (actual)
First posted: 8 Aug 2017 (actual)
Results: Posted 12 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
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).

Arm	Type	Receives
Sham tACS	Sham comparator	Device: XCSITE100 Stimulator ShamSham 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.
Active 10 Hz tACS	Active comparator	Device: XCSITE100 Stimulator tACSParticipants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
XCSITE100 Stimulator ShamAlso: Sham tACSThe 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	Sham tACS
XCSITE100 Stimulator tACSAlso: tACSTranscranial 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	Device	Active 10 Hz tACS

Primary outcome

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
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

1 secondary outcome

Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation
Time frame: before and after 40 minute stimulation session

Results and safety

Results posted to the registry on 12 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Then Active 10 Hz tACS	11	11
Active 10 Hz Then Sham tACS	10	10

Primary outcome: Change in Heart Rate Variability Before and After 40-minute Stimulation

Time frame: before and after 40-minute stimulation at each session. Mean (Standard Deviation). Unit: ms^2

Measure	Sham tACS n = 20	Active10 Hz tACS n = 20
Value	0.206 (0.76)	-0.01 (0.56)

Sham tACS vs Active10 Hz tACS: p = .319, ANOVA

Primary outcome: 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.. Mean (Standard Deviation). Unit: square microvolts

Measure	Sham tACS n = 20	Active 10 Hz tACS n = 20
Value	0.03 (0.16)	0.4 (0.15)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Study enrollment until 2 day followup after last session. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham tACS	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Active 10 Hz tACS	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31849514Prim 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.
Derived from this study: PubMed 30268803Ahn 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.
Individual participant dataSharing planned: Undecided. No Plan

Related trials for Chronic Low Back Pain

Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen McCulloch, PhD, DPT principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing XCSITE100 Stimulator tACS in people with Chronic Low Back Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Heart Rate Variability Before and After 40-minute Stimulation (time frame: before and after 40-minute stimulation at each session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03243084, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.