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

Phase 1

Completed

• Conditions: Depression; Post-traumatic Stress Disorder
• Interventions: Procedure: Transcutaneous Electrical Nerve Stimulator (TENS)

• Registration Number: NCT01335217
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label TNS treatment	Transcutaneous Electrical Nerve Stimulator (TENS)	There is only one arm in this open label treatment of MDD co-occuring with PTSD.

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale-17 Item	Baseline, week 8
Change in PTSD Checklist score	Baseline, Week 8

Secondary Outcome Measures

Name	Time	Method
Change in life functional capacity and quality of life scales	baseline, week 8	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	At every visit for 8 weeks	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	At every visit for 8 weeks	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)

Trial Locations

Locations (1)

Semel Institute for Neuroscience and Human Behavior at UCLA; 🇺🇸 Los Angeles, California, United States