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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH101547 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | before and after 40 minute stimulation session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen McCulloch, PhD, DPT | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31849514 | Derived | 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. | |
| 30268803 | 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. |
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No Plan
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Recruitment ran from August 2017 - December 2017. This clinical trial utilized multiple recruitment strategies including UNC University Physical Therapy and Pain clinic locations, informational notify.unc.edu system, and jointheconquest.org along with the listing on clinicaltrials.gov
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Then Active 10 Hz tACS | At session 1 this group received sham tACS and at session 2 they received active 10Hz tACS |
| FG001 | Active 10 Hz Then Sham tACS | At session 1 this group received active 10Hz tACS and at session 2 they received sham tACS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Session 1 |
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| Washout (1-3 Weeks) |
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| Session 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Then Active 10 Hz tACS | At session 1 this group received sham tACS and at session 2 they received active 10Hz tACS |
| BG001 | Active 10 Hz Then Sham tACS | At session 1 this group received active 10Hz tACS and at session 2 they received sham 10Hz tACS |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | ms^2 | before and after 40-minute stimulation at each session |
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Study enrollment until 2 day followup after last session
A side effects questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham tACS | 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. 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julianna Prim | UNC Chapel Hill | 919-962-5271 | jhprim@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2017 | Sep 13, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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).
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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.
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| 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 |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Duration of Pain | Mean | Standard Deviation | years |
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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. 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 |
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| Primary | 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 | Posted | Mean | Standard Deviation | square microvolts | 5 minute recordings before and after each 40-minute stimulation at each session. |
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| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | before and after 40 minute stimulation session |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Active 10 Hz tACS | 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. 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |