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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
  • 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
Sham Comparator
Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
  • 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

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
Contact:
Melba Hernandez-Tejada, PhD, DHA
713 4862729
Melba.A.HernandezTejada@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Melba Hernandez-Tejada, PhD, DHA
713 4862729
Melba.A.HernandezTejada@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.