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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ian A. Cook, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01335217
First received: April 5, 2011
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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:

  1. Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period.
  2. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS.
  3. Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.

Condition Intervention Phase
Depression
Post-traumatic Stress Disorder
Procedure: Transcutaneous Electrical Nerve Stimulator (TENS)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trigeminal Nerve Stimulation for PTSD and Depression

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale-17 Item [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
  • Change in PTSD Checklist score [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in life functional capacity and quality of life scales [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    Life functional capacity and quality of life scales include: Short-form Health Survey-36 Item and Quality of Life Enjoyment and Satisfaction Questionnaire

  • Changes in vital signs recordings [ Time Frame: At every visit for 8 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Changes in Safety Assessment Measures [ Time Frame: At every visit for 8 weeks ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open-label TNS treatment
There is only one arm in this open label treatment of MDD co-occuring with PTSD.
Procedure: Transcutaneous Electrical Nerve Stimulator (TENS)
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Outpatients with non-psychotic, unipolar Major Depressive Disorder AND Posttraumatic Stress Disorder, assessed via the MINI structured interview
  2. A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
  3. A score of ≥ 50 on the CAPS (Clinical-Administered PTSD Scale for DSM-IV)
  4. 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)
  5. 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

  1. Patient is mentally or legally incapacitated, unable to give informed consent.
  2. 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.
  3. Patients with exposure to ECT or VNS within the past 6 months.
  4. 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.
  5. 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.
  6. Other medical contraindications to any of the study procedures
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335217

Locations
United States, California
Semel Institute for Neuroscience and Human Behavior at UCLA
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Ian A Cook, M.D. Semel Institute for Neuroscience and Human Behavior
  More Information

No publications provided

Responsible Party: Ian A. Cook, M.D., Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01335217     History of Changes
Other Study ID Numbers: 10-000894, 10-000894
Study First Received: April 5, 2011
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Depression
Major Depressive Disorder (MDD)
Trigeminal Nerve Stimulation
Post Traumatic Stress Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on August 21, 2014