Post-traumatic Stress DisorderNCT05112003
Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot
A study testing Translingual neurostimulation in people with Post-traumatic Stress Disorder, run by HealthTech Connex Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Translingual neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2021to 6 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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:
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Translingual neurostimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translingual neurostimulationDevice
The device will be placed into and held in the participant's mouth for 20 minutes while the participant undergoes breathing and awareness training
| Study group | Role | What they receive |
|---|---|---|
| TLNS | Experimental | Translingual neurostimulation will be paired with breathing and awareness training prior to CPT sessions Receives: Device: Translingual neurostimulation |
| Control | No intervention | No TLNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants screened who are eligible
Reach (RE-AIM framework)
Measured: Baseline to week 6
Clinician-rated symptom severity as measured by CAPS
Effectiveness (RE-AIM framework)
Measured: Change from baseline to week 6
Participant rated symptom severity as measured by the PCL-5
Effectiveness (RE-AIM framework)
Measured: Change from baseline to week 6
Proportion of therapy visits completed
Adoption (RE-AIM framework)
Measured: Baseline to Week 6
Ease of protocol administration
Adoption (RE-AIM framework); 5-point Likert scale for participants and therapists
Measured: Baseline to week 6
Qualitative report of barriers and facilitators
Implementation (RE-AIM framework)
Measured: Baseline to week 6
Secondary outcomes (7)
Electroencephalography (EEG)
Using the NeuroCatchTM Platform - EEG amplitudes
Measured: Change from baseline to week 6
Electroencephalography (EEG)
Using the NeuroCatchTM Platform - EEG latencies
Measured: Change from baseline to week 6
Generalized Anxiety Disorder 7-item (GAD-7)
Anxiety symptom severity self-report measure
Measured: Change from baseline to week 6
Patient Health Questionnaire (PHQ-9)
Depression symptom severity self-report measure
Measured: Change from baseline to week 6
Brief Inventory of Psychosocial Functioning (B-IPF)
PTSD-related functional impairment in the prior 30 days
Measured: 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
Measured: Change from baseline to week 6
Time from inciting event
Time since traumatic event (years)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start22 Sep 2021
- Primary completion12 Apr 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthTech Connex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Neurology Studies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112003
- Sponsor's protocol ID
- HTC_PTSD_001
- Status last verified
- Aug 2023
- First submitted
- 15 Oct 2021
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot
- ClinicalTrials.gov ID
- NCT05112003
- Acronym / sponsor ID
- HTC_PTSD_001
- Conditions
- Post-traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- HealthTech Connex Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre for Neurology Studies
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLNS | Experimental | Device: Translingual neurostimulationTranslingual neurostimulation will be paired with breathing and awareness training prior to CPT sessions |
| Control | No intervention | –No TLNS |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translingual neurostimulationThe device will be placed into and held in the participant's mouth for 20 minutes while the participant undergoes breathing and awareness training | Device | TLNS |
Primary outcome
Proportion of participants screened who are eligible
Time frame: Baseline to week 6
Reach (RE-AIM framework)
Clinician-rated symptom severity as measured by CAPS
Time frame: Change from baseline to week 6
Effectiveness (RE-AIM framework)
Participant rated symptom severity as measured by the PCL-5
Time frame: Change from baseline to week 6
Effectiveness (RE-AIM framework)
Proportion of therapy visits completed
Time frame: Baseline to Week 6
Adoption (RE-AIM framework)
Ease of protocol administration
Time frame: Baseline to week 6
Adoption (RE-AIM framework); 5-point Likert scale for participants and therapists
Qualitative report of barriers and facilitators
Time frame: Baseline to week 6
Implementation (RE-AIM framework)
7 secondary outcomes
Electroencephalography (EEG)
Time frame: Change from baseline to week 6
Electroencephalography (EEG)
Time frame: Change from baseline to week 6
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Change from baseline to week 6
Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline to week 6
Brief Inventory of Psychosocial Functioning (B-IPF)
Time frame: Change from baseline to week 6
Meaning in Life Questionnaire (MLQ)
Time frame: Change from baseline to week 6
Time from inciting event
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Study sign-up pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Post-traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Translingual neurostimulation in people with Post-traumatic Stress Disorder, run by HealthTech Connex Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants screened who are eligible (time frame: Baseline to week 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.