Chronic Pain, Depression, Post Traumatic Stress Disorder (PTSD)
Conditions
Keywords
Transcranial direct current stimulation (tDCS), Veterans
Brief summary
The Veteran population has been known to deal with co-morbid chronic pain and PTSD. As a result, they use healthcare services at a higher rate than those Veterans with pain or PTSD alone which leads to an amplified burden on healthcare systems. tDCS is a painless brain stimulation treatment that uses direct electrical currents (at a constant, low-intensity level) to stimulate specific parts of the brain and help modulate neuronal activity. This study hypothesizes that our short-term therapy-focused treatment program coupled with tDCS administrations will aid in the reduction of chronic pain and PTSD symptoms. Secondly, the investigators intend to examine any relationships between BDNF reduction in reported pain and PTSD and related mental health symptoms. Subjects will be identified from the Emory Healthcare Veterans Program (EHVP-IOP) Veterans and Service members seeking psychiatric treatment for mental health issues including PTSD.
Detailed description
The Veteran population has been known to deal with co-morbid chronic pain and PTSD. As a result, they use healthcare services at a higher rate than those Veterans with pain or PTSD alone which leads to an amplified burden on healthcare systems. In the process of seeking relief and treatment in the healthcare systems, Veterans may use opioid medications to treat chronic pain which puts them at risk for harmful consequences. This study will be an open trial providing a non-opioid, self-administered, effective pain intervention as part of an effective mental health treatment program. A transcranial direct current stimulation (tDCS) device will be utilized in combination with a cognitive-behavioral therapy (CBT) focused intensive outpatient program (IOP). Additionally, blood and saliva will be collected during this study to perform brain derived neurotropic factor (BDNF) assays comparing outcomes from specific visits: pre-treatment (tx), mid-tx, and post-tx. The study will take place at the Brain Health Center (BHC) located at 12 Executive Park in the Veterans Program Department. Subjects will be identified from the Emory Healthcare Veterans Program (EHVP-IOP) Veterans and Service members seeking psychiatric treatment for mental health issues. Incoming patients will be screened for this study and consented prior to the start of their treatment program participation. An electronic consent will be conducted using the REDCap e-Consent framework. A partial waiver of consent is requested to be able to review identifiable information to determine a potential subject's eligibility status. This study hypothesizes that our short-term therapy-focused treatment program coupled with tDCS administrations will aid in the reduction of chronic pain . Secondly, we intend to examine reductions in PTSD and related mental health symptoms and any relationships between BDNF reduction in reported pain and PTSD and related mental health symptoms.
Interventions
DEVICEtDCS
tDCS is a painless brain stimulation treatment that uses direct electrical currents (at a constant, low-intensity level) to stimulate specific parts of the brain and help modulate neuronal activity. Participants will receive a series of tDCS treatments during the Intensive Outpatient Program (IOP) coupled with blood and saliva collections. Participants will administer a stimulation session via the Soterix 1x1 tDCS mini-CT Stimulator, after being provided a single-use code to unlock the device by the research staff once proper contact quality is achieved. After the participant enters the unlock code, the screen on the device will show a timer that counts down the minutes until the end of the session. After 20 min, the device will turn off automatically and the study staff will instruct the participant to remove the headset and discard the sponges and to store safely all materials for the next session.
Sponsors
Emory University
Wounded Warrior Project
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female, 18 -89 years old * Treated on site for EHVP IOP * For long-term follow-up, must live in Georgia or Florida * Eligible for EHVP-IOP PTSD or Unified Protocol tracks * Willing to self-administer tDCS and complete the measures * DVPRS pain intensity of 4 or more for most of the day at least 3 days per week * Have an established PCP (Primary Care Provider) or pain management provider
Exclusion criteria
* Implanted pacemaker * Seizure Disorder * Pregnancy, if applicable * Any new onset of the following: * Balance problems * Difficulty walking * Bladder incontinence * Bowel incontinence * Numbness * Tingling * Weakness * Medical contraindications: * Current use of sodium channel blockers * Lidocaine (OTC/transdermal delivery is ok) * Mexiletine * Amitriptyline; other tricyclic antidepressants * Anti-epileptic medications * Phenytoin, carbamazepine, lamotrigine, oxcarbazepine, rufinamide, lacosamide and eslicarbazepine acetate * Current use of calcium channel blockers * Current use of N-Methyl-D-aspartate receptor antagonists * Ketamine * Dextromethorphan * Felbamate * History of brain surgery * History of brain tumor * History of seizure disorder * History of stroke * Intracranial metal implantation * Adults unable to consent * Individuals who are not yet adults * Prisoners * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Defense and Veterans Pain Rating Scale (DVPRS): Pain Intensity | Intake, Days 1,5, 8 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up | The DVPRS assesses chronic pain using a visual analogue scale of 0 to 10, including general level of pain, and assessment of interference with daily activities, mood, sleep, and stress in 5 subscales. It is widely used in clinical care and research and has demonstrated reliability and validity within the military and Veteran population. This is a clinical measure collected per standard of care at intake. However, this measure was collected for research purposes at additional timepoints, including each tDCS session, 1-10, and all follow-up visits. For each subscale, this is a visual analogue scale of 0 to 10, with higher scores meaning more intensity or interference |
| Changes in Defense and Veterans Pain Rating Scale (DVPRS): Activity | Intake, Days 1,5, 8 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up | The DVPRS assesses chronic pain using a visual analogue scale of 0 to 10, including general level of pain, and assessment of interference with daily activities, mood, sleep, and stress in 5 subscales. It is widely used in clinical care and research and has demonstrated reliability and validity within the military and Veteran population. This is a clinical measure collected per standard of care at intake. However, this measure was collected for research purposes at additional timepoints, including each tDCS session, 1-10, and all follow-up visits. For each subscale, this is a visual analogue scale of 0 to 10, with higher scores meaning more intensity or interference |
| Changes in Defense and Veterans Pain Rating Scale (DVPRS): Mood | Intake, Days 1,5, 8 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up | The DVPRS assesses chronic pain using a visual analogue scale of 0 to 10, including general level of pain, and assessment of interference with daily activities, mood, sleep, and stress in 5 subscales. It is widely used in clinical care and research and has demonstrated reliability and validity within the military and Veteran population. This is a clinical measure collected per standard of care at intake. However, this measure was collected for research purposes at additional timepoints, including each tDCS session, 1-10, and all follow-up visits. For each subscale, this is a visual analogue scale of 0 to 10, with higher scores meaning more intensity or interference |
| Changes in Defense and Veterans Pain Rating Scale (DVPRS): Sleep | Intake, Days 1,5, 8 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up | The DVPRS assesses chronic pain using a visual analogue scale of 0 to 10, including general level of pain, and assessment of interference with daily activities, mood, sleep, and stress in 5 subscales. It is widely used in clinical care and research and has demonstrated reliability and validity within the military and Veteran population. This is a clinical measure collected per standard of care at intake. However, this measure was collected for research purposes at additional timepoints, including each tDCS session, 1-10, and all follow-up visits. For each subscale, this is a visual analogue scale of 0 to 10, with higher scores meaning more intensity or interference |
| Changes in Defense and Veterans Pain Rating Scale (DVPRS): Stress | Intake, Days 1,5, 8 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up | The DVPRS assesses chronic pain using a visual analogue scale of 0 to 10, including general level of pain, and assessment of interference with daily activities, mood, sleep, and stress in 5 subscales. It is widely used in clinical care and research and has demonstrated reliability and validity within the military and Veteran population. This is a clinical measure collected per standard of care at intake. However, this measure was collected for research purposes at additional timepoints, including each tDCS session, 1-10, and all follow-up visits. For each subscale, this is a visual analogue scale of 0 to 10, with higher scores meaning more intensity or interference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in PROMIS 3a Pain Intensity | Day 1 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up | Patient-reported outcome (PRO) measures use answers provided directly by patients to assess their symptoms, functioning, and overall well-being. The PROMIS Pain Intensity Short Form 3a assesses pain intensity using three patient-reported items: (1) pain intensity at its worst during the past 7 days, (2) average pain intensity during the past 7 days, and (3) pain intensity right now. Each item is rated on a 5-point scale ranging from 1 (no pain) to 5 (very severe pain). Responses to the three items are summed to obtain a raw score ranging from 3 to 15, with higher scores indicating greater pain intensity. |
| Changes in PROMIS 8a Pain Interference | Day 1 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up | The PROMIS Pain Interference Short Form 8a assesses the self-reported impact of pain on daily functioning and quality of life. The instrument consists of 8 items evaluating the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities, as well as enjoyment of life and sleep, over the past 7 days. Example items include: "In the past 7 days, how much did pain interfere with your day-to-day activities?" and "In the past 7 days, how much did pain interfere with the things you usually do for fun?" Each item is rated on a 5-point scale ranging from 1 (Not at all) to 5 (Very much). Item scores are summed to obtain a total raw score ranging from 8 to 40, where higher scores indicate greater pain interference and a worse outcome. Patient-reported outcome (PRO) measures use responses provided directly by patients to assess symptoms, functioning, and overall well-being. |
| PTSD Checklist- PCL-5 | Baseline, Days 1 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up | The PCL-5 is a 20-item self-report measure of PTSD severity in the past week, during treatment, and a month for follow-up. Each item ranges from 0 (not at all) to 4 (extremely). Total scores range from 0 to 80. Cut points and psychometrics are pulled from the most recent studies on the new PCL-5. This is a clinical measure collected per standard of care. |
| Patient Health Questionnaire- 9 (PHQ-9) | Intake, Days 1 and 12 of intervention and at months 1, 3, 6, 9, and 12 of follow-up. | The PHQ-9 is a 9-item, well-validated measure of depression and a secondary outcome. The PHQ-9 assesses symptoms of major depression in the past two weeks from 0 (not at all) to 3 (nearly every day) and has excellent internal and test-retest reliability as well as construct and criterion validity (80). The PHQ-9 is effective in detecting treatment changes in depression in PC settings. Score on a scale sum of all 9 items rated on a 0 (not at all) to 3 (nearly every day) scale, with higher meaning more depressed. Total scores range from 0 to 27. |
| Brain-derived Neurotrophic Factor (BDNF) in Blood | Days 2, 5 and 11 of the intervention | On each study day (Days 2, 5, 7, 11), three samples were obtained: before the transcranial direct current stimulation (tDCS) session, immediately before the therapy session, and after the therapy session. BDNF concentrations were measured in pg/mL. To quantify within-day changes in BDNF, measurements from the three time points were combined using the Area Under the Curve with Respect to Increase (AUCI) method described by Pruessner et al. (2003). The resulting AUCI values were log-transformed to improve the normality of the distribution. AUCI values may be positive or negative and have no predefined minimum or maximum value. Positive values indicate an overall increase in BDNF concentrations across the session, whereas negative values indicate that later BDNF measurements were lower than the initial measurement. Higher values reflect a greater increase in BDNF during the study |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSheila Rauch, PhD
Emory University
PRINCIPAL_INVESTIGATORBarbara O Rothbaum
Emory University
PRINCIPAL_INVESTIGATORBoadie W Dunlop, MD
Emory University
Participant flow
Recruitment details
Participants were recruited from Emory Psychiatry Clinic. Participant enrollment began March 2, 2022 and all follow-up assessments were completed by June 7, 2024.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 8.61 |
| Pain type Fibromyalgia | 1 Participants |
| Pain type Joint | 32 Participants |
| Pain type migraine | 3 Participants |
| Pain type Other | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latinx | 6 Participants |
| Race/Ethnicity, Customized Not Hispanic/ Latinx | 28 Participants |
| Race/Ethnicity, Customized Unknown/no response | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex/Gender, Customized Female | 16 Participants |
| Sex/Gender, Customized Male | 20 Participants |
| Sex/Gender, Customized Trans or Gender non confirming | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
None listed