Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot

NCT05112003 | Completed

• 1 other identifier: HTC_PTSD_001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A growing body of evidence suggests that translingual neurostimulation (TLNS) plays a role in modulating neuroplastic changes in the brain, which has far-reaching implications for its ability to facilitate other therapeutic interventions such as cognitive processing therapy (CPT) for post-traumatic stress disorder (PTSD). The present study aims to assess the feasibility of combining TLNS with CPT in individuals with PTSD.

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (6)

• Proportion of participants screened who are eligible

  Reach (RE-AIM framework)

  Baseline to week 6

• Clinician-rated symptom severity as measured by CAPS

  Effectiveness (RE-AIM framework)

  Change from baseline to week 6

• Participant rated symptom severity as measured by the PCL-5

  Effectiveness (RE-AIM framework)

  Change from baseline to week 6

• Proportion of therapy visits completed

  Adoption (RE-AIM framework)

  Baseline to Week 6

• Ease of protocol administration

  Adoption (RE-AIM framework); 5-point Likert scale for participants and therapists

  Baseline to week 6

• Qualitative report of barriers and facilitators

  Implementation (RE-AIM framework)

  Baseline to week 6

Secondary Outcomes (7)

• Electroencephalography (EEG)

  Change from baseline to week 6

• Electroencephalography (EEG)

  Change from baseline to week 6

• Generalized Anxiety Disorder 7-item (GAD-7)

  Change from baseline to week 6

• Patient Health Questionnaire (PHQ-9)

  Change from baseline to week 6

• Brief Inventory of Psychosocial Functioning (B-IPF)

  Change from baseline to week 6

Study Arms (2)

TLNS

EXPERIMENTAL

Translingual neurostimulation will be paired with breathing and awareness training prior to CPT sessions

Device: Translingual neurostimulation

Control

NO INTERVENTION

No TLNS

Interventions

Translingual neurostimulation DEVICE

The device will be placed into and held in the participant's mouth for 20 minutes while the participant undergoes breathing and awareness training

TLNS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, at least 19 years of age or older
• A score of 33 or more on the Posttraumatic Stress Disorder Checklist (PCL-5)
• PTSD symptom duration of ≥ 12 months
• Stable dose of any medications for the last three months, with no changes anticipated for the duration of the study
• Adequate support at home (e.g., family member or caregiver) to ensure assistance in seeking access to help if needed
• Able to understand the informed consent form, study procedures and willing to participate in study
• Currently has a primary care provider

You may not qualify if:

• History of substance dependence or abuse (within the last 3 months)
• Unstable psychosocial settings (homelessness, lack of support at home)
• Moderate to high risk of suicidal ideation or behaviour as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
• Current diagnosis of severe anxiety (or score of ≥15 on the GAD-7), severe depression (or score of ≥20 on the PHQ-9), schizophrenia or bipolar disorder
• Use of medications for PTSD within the last 6 weeks
• History of other major neurological disorder (brain cancer, dementia, multiple sclerosis, stroke)
• Detection of mild cognitive impairment (mini-ACE score of ≤ 25)
• Diagnosed epilepsy or history of seizures
• Not proficient in English
• Recent (within last 2 years) acquired brain injury
• Exposed to an investigational drug or device 30 days prior to starting the study, or concurrent use of an investigational drug or device while enrolled in the study
• If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
• Contraindicated for the NeuroCatchTM Platform, including:
• Requires the use of hearing aids or a cochlear implant 13.2. Diagnosed with tinnitus that is currently active 13.3. Has temporary damage to earing (e.g. punctured ear drum) 13.4. Unable to detect a 740Hz tone played at 85dB in both ears. 13.5. Implanted pacemaker or implanted electrical stimulators 13.6. Metal or plastic implants in the skull, excluding dental/facial implants 13.7. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin) 13.8. Previous exposure to the NeuroCatch™ Platform audio sequences in the last 3 months
• Contraindicated for PoNSTM use, including:

Sponsors & Collaborators

• HealthTech Connex Inc.: lead
• Centre for Neurology Studies: collaborator

Study Sites (1)

Centre for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

Location

Related Links

• Study sign-up page

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 8, 2021
• Study Start: September 22, 2021
• Primary Completion: April 12, 2023
• Study Completion: July 6, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

CA (1)