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

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.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Device: Translingual neurostimulation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Centre for Neurology Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. History of substance dependence or abuse (within the last 3 months)
2. Unstable psychosocial settings (homelessness, lack of support at home)
3. Moderate to high risk of suicidal ideation or behaviour as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
4. 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
5. Use of medications for PTSD within the last 6 weeks
6. History of other major neurological disorder (brain cancer, dementia, multiple sclerosis, stroke)
7. Detection of mild cognitive impairment (mini-ACE score of ≤ 25)
8. Diagnosed epilepsy or history of seizures
9. Not proficient in English
10. Recent (within last 2 years) acquired brain injury
11. 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
12. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding

13. Contraindicated for the NeuroCatchTM Platform, including:

    13.1. 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

14. Contraindicated for PoNSTM use, including:

14.1. Current disease or sensitivity of the oral cavity 14.2. History of oral cancer 14.3. Oral surgery within three months of screening 14.4. Oral cavity piercings that could interfere with PoNSTM use 14.5. Sensitivity to Nickel, Copper, or Gold 14.6. Currently enrolled in a PoNSTM treatment program or use of the PoNSTM device in the last 5 weeks 14.7. History of penetrating brain injuries 14.8. History of neurodegenerative diseases 14.9. Chronic infectious disease 14.10. Unmanaged hypertension 14.11. Diabetes 14.12. History of seizures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TLNS; Translingual neurostimulation will be paired with breathing and awareness training prior to CPT sessions	Device: Translingual neurostimulation; The device will be placed into and held in the participant's mouth for 20 minutes while the participant undergoes breathing and awareness training
No Intervention: Control; No TLNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalography (EEG)	Using the NeuroCatchTM Platform - EEG amplitudes	Change from baseline to week 6
Electroencephalography (EEG)	Using the NeuroCatchTM Platform - EEG latencies	Change from baseline to week 6
Generalized Anxiety Disorder 7-item (GAD-7)	Anxiety symptom severity self-report measure	Change from baseline to week 6
Patient Health Questionnaire (PHQ-9)	Depression symptom severity self-report measure	Change from baseline to week 6
Brief Inventory of Psychosocial Functioning (B-IPF)	PTSD-related functional impairment in the prior 30 days	Change from baseline to week 6
Meaning in Life Questionnaire (MLQ)	Assesses two dimensions of meaning in life using 10 items rated on a seven-point scale	Change from baseline to week 6
Time from inciting event	Time since traumatic event (years)	Baseline

Collaborators and Investigators

• Sponsor: HealthTech Connex Inc.
• Collaborators: Centre for Neurology Studies

Publications and helpful links

Helpful Links

• Study sign-up page

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2021
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HTC_PTSD_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No