Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Integrated Treatment for Pain and PTSD

Official title

Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Entirely Remote 2-Week Integrated Treatment for Pain and PTSD

Overview

The purpose of this study is to examine comparative effectiveness of two home-based telemedicine delivered interventions: transcranial Direct Current Stimulation (tDCS) combined with Massed Prolonged Exposure (Massed-PE) vs. Sham tDCS combined with Massed PE, focusing on pain and PTSD outcomes, to determine the comparative effectiveness of the two interventions on process outcomes of patient satisfaction, treatment attrition, and treatment compliance and to explore changes in blood biomarkers associated with stress and inflammatory processes related to pain and PTSD symptom improvements following treatment.

Interventions

• Device Transcranial Direct Current Stimulation (tDCS)
  A constant current intensity of 2 Ma electrical current will be administered for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday)using the headgear M1-SO montage placement.
• Behavioral Massed-Prolonged Exposure (PE)
  PE will include a) psychoeducation about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 10), c) repeated, prolonged, imaginal exposure to traumatic memories (sessions 3 through 10). All sessions will be delivered via telehealth.
• Device Sham Transcranial Direct Current Stimulation (tDCS)
  Sham tDCS delivers an active stimulation of 2 Ma electrical current) for a few seconds to mimic the sensations of active tDCS

Primary outcome measures

• Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS) [Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months]
• Change in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5) [Time frame: Baseline, post treatment (after session 10) 3 months, 6 months]

Secondary outcome measures (7)

• Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale [Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months]
• Change in pain interference as assessed by the PROMIS Pain 8a Interference Scale [Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months]
• Change in symptoms of Post-Traumatic Stress Disorder (PTSD)as assessed by the PTSD Checklist-5 Civilian (PCL-5) [Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months]
• Change in Quality of life as assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF) [Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months]
• Change in anxiety as assessed by the Generalized Anxiety Disorder Scale 7 (GAD-7) [Time frame: Baseline,post treatment (after session 10) 3 months, 6 months]
• Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline, post treatment (after session 10) 3 months, 6 months]
• Change in depression as assessed by the The Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, post treatment (after session 10) 3 months, 6 months]

Eligibility criteria

Inclusion criteria

• Presence of musculoskeletal, chronic, non-cancer pain with a rating of ≥ 3 out of 10 on a 0-10 on the Defense and Veterans Pain Rating Scale (DVPRS) and a pain intensity and interference score of 1 standard deviation above PROMIS normative data (see Measures section below). Symptoms will be required to be of at least six months duration and verified diagnosis in their medical chart authorized by informed consent
• Diagnosis of PTSD assigned on the basis of the Clinician Administered PTSD Scale (CAPS-5) and PCL-5 ≥ 30
• willing to participate in study randomization, treatment assignment, and assessments.

Exclusion criteria

• Having a household member who is already enrolled in the study
• Active psychosis or dementia at screening
• Suicidal ideation with clear intent
• Current substance dependence
• current opioid medication for pain and/or current use of sodium channel blockers, calcium channel blockers, or N-Methyl-D-aspartate receptor antagonists, because these medications can block tDCS effects
• pregnancy and/or lactation
• concurrent enrollment in another pain clinical trial
• tDCS or medical related contraindications such as open-injury TBI (penetrating injury), seizure disorder (independently of the type of TBI or condition causing the seizure disorder), pregnancy, implanted metal, claustrophobia
• having pain that is not chronic, presence of severe and frequent migraines, fibromyalgia, or pain caused by a primary condition such as cancer.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Charleston VA Healthcare System — Charleston
• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07116109 · HSC-MS-25-0436

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗