Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression

Study Overview
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Brief Summary
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This is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Our primary objective is the examination of TNS in this patient population. To accomplish our specific aims, the investigators will test the following specific hypotheses: Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS. Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.

Detailed Description
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A total of 20 subjects with Major Depressive Disorder (MDD) co-occurring with Post Traumatic Stress Disorder (PTSD), ages 18 to 75 years, will be consented and join this project at UCLA. The project will use TNS in under open-label conditions, using the same stimulation parameters as have been used in prior studies in MDD by itself and in treatment-refractory epilepsy. Subjects will be seen every two weeks during the 8 week study. At the end of the 8 weeks, the TNS systems will be returned and the adjunctive treatment will end. The co-primary endpoints are the changes in depression severity and in PTSD severity from enrollment to the week 8 visit.

Official Title
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Trigeminal Nerve Stimulation for PTSD and Depression

Conditions
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Depression, Post-traumatic Stress Disorder

Intervention / Treatment
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* Procedure: Transcutaneous Electrical Nerve Stimulator (TENS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Outpatients with non-psychotic, unipolar Major Depressive Disorder AND Posttraumatic Stress Disorder, assessed via the MINI structured interview A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2 A score of ≥ 50 on the CAPS (Clinical-Administered PTSD Scale for DSM-IV) A history of treatment failure with at least one adequate trial of an antidepressant over the previous 6 weeks, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study) Age range: 18 to 75. 6) Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm. Exclusion Criteria Patient is mentally or legally incapacitated, unable to give informed consent. Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive- compulsive disorder (lifetime); acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded. Patients with exposure to ECT or VNS within the past 6 months. Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis. current pregnancy, breast feeding, plans to become pregnant in the 12-week treatment phase of the study, or not using a medically accepted means of contraception. Other medical contraindications to any of the study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open-label TNS treatment<br>There is only one arm in this open label treatment of MDD co-occuring with PTSD. | Procedure: Transcutaneous Electrical Nerve Stimulator (TENS)<br>* External trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Depression Rating Scale-17 Item |  | Baseline, week 8 | 
| Change in PTSD Checklist score |  | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in life functional capacity and quality of life scales | Life functional capacity and quality of life scales include: Short-form Health Survey-36 Item and Quality of Life Enjoyment and Satisfaction Questionnaire | baseline, week 8 | 
| Changes in vital signs recordings | Autonomic function (i.e. pulse and blood pressure) are monitored for 30 mins of stimulation at baseline. Resting vital signs are recorded for each visit. | At every visit for 8 weeks | 
| Changes in Safety Assessment Measures | Safety Assessment measures will be administered at each visit and include: Survey of Acceptability of TNS, Systematic Assessment for Treatment Emergent Events-Systematic Inquiry (SAFTEE-SI), and Frequency, Intensity, and Burden of Side Effects Scale (FIBSER) | At every visit for 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trigeminal Nerve Stimulation, Depression, Major Depressive Disorder (MDD), Post Traumatic Stress Disorder