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

August 1, 2023 updated by: HealthTech Connex Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of participants screened who are eligible
Time Frame: Baseline to week 6
Reach (RE-AIM framework)
Baseline to week 6
Clinician-rated symptom severity as measured by CAPS
Time Frame: Change from baseline to week 6
Effectiveness (RE-AIM framework)
Change from baseline to week 6
Participant rated symptom severity as measured by the PCL-5
Time Frame: Change from baseline to week 6
Effectiveness (RE-AIM framework)
Change from baseline to week 6
Proportion of therapy visits completed
Time Frame: Baseline to Week 6
Adoption (RE-AIM framework)
Baseline to Week 6
Ease of protocol administration
Time Frame: Baseline to week 6
Adoption (RE-AIM framework); 5-point Likert scale for participants and therapists
Baseline to week 6
Qualitative report of barriers and facilitators
Time Frame: Baseline to week 6
Implementation (RE-AIM framework)
Baseline to week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electroencephalography (EEG)
Time Frame: Change from baseline to week 6
Using the NeuroCatchTM Platform - EEG amplitudes
Change from baseline to week 6
Electroencephalography (EEG)
Time Frame: Change from baseline to week 6
Using the NeuroCatchTM Platform - EEG latencies
Change from baseline to week 6
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame: Change from baseline to week 6
Anxiety symptom severity self-report measure
Change from baseline to week 6
Patient Health Questionnaire (PHQ-9)
Time Frame: Change from baseline to week 6
Depression symptom severity self-report measure
Change from baseline to week 6
Brief Inventory of Psychosocial Functioning (B-IPF)
Time Frame: Change from baseline to week 6
PTSD-related functional impairment in the prior 30 days
Change from baseline to week 6
Meaning in Life Questionnaire (MLQ)
Time Frame: Change from baseline to week 6
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 Frame: Baseline
Time since traumatic event (years)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HealthTech Connex Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre for Neurology Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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