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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05112003
Recruitment Status : Active, not recruiting
First Posted : November 8, 2021
Last Update Posted : March 7, 2023
Sponsor:
Collaborator:
Centre for Neurology Studies
Information provided by (Responsible Party):
HealthTech Connex Inc.

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Device: Translingual neurostimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot
Actual Study Start Date : September 22, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Proportion of participants screened who are eligible [ Time Frame: Baseline to week 6 ]
    Reach (RE-AIM framework)

  2. Clinician-rated symptom severity as measured by CAPS [ Time Frame: Change from baseline to week 6 ]
    Effectiveness (RE-AIM framework)

  3. Participant rated symptom severity as measured by the PCL-5 [ Time Frame: Change from baseline to week 6 ]
    Effectiveness (RE-AIM framework)

  4. Proportion of therapy visits completed [ Time Frame: Baseline to Week 6 ]
    Adoption (RE-AIM framework)

  5. Ease of protocol administration [ Time Frame: Baseline to week 6 ]
    Adoption (RE-AIM framework); 5-point Likert scale for participants and therapists

  6. Qualitative report of barriers and facilitators [ Time Frame: Baseline to week 6 ]
    Implementation (RE-AIM framework)


Secondary Outcome Measures :
  1. Electroencephalography (EEG) [ Time Frame: Change from baseline to week 6 ]
    Using the NeuroCatchTM Platform - EEG amplitudes

  2. Electroencephalography (EEG) [ Time Frame: Change from baseline to week 6 ]
    Using the NeuroCatchTM Platform - EEG latencies

  3. Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: Change from baseline to week 6 ]
    Anxiety symptom severity self-report measure

  4. Patient Health Questionnaire (PHQ-9) [ Time Frame: Change from baseline to week 6 ]
    Depression symptom severity self-report measure

  5. Brief Inventory of Psychosocial Functioning (B-IPF) [ Time Frame: Change from baseline to week 6 ]
    PTSD-related functional impairment in the prior 30 days

  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

  7. Time from inciting event [ Time Frame: Baseline ]
    Time since traumatic event (years)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05112003


Locations
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Canada, British Columbia
Centre for Neurology Studies
Surrey, British Columbia, Canada, V3V 0C6
Sponsors and Collaborators
HealthTech Connex Inc.
Centre for Neurology Studies
Additional Information:
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Responsible Party: HealthTech Connex Inc.
ClinicalTrials.gov Identifier: NCT05112003    
Other Study ID Numbers: HTC_PTSD_001
First Posted: November 8, 2021    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders