Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression
|ClinicalTrials.gov Identifier: NCT01335217|
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : February 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Post-traumatic Stress Disorder||Procedure: Transcutaneous Electrical Nerve Stimulator (TENS)||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trigeminal Nerve Stimulation for PTSD and Depression|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
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
- Change in Hamilton Depression Rating Scale-17 Item [ Time Frame: Baseline, week 8 ]
- Change in PTSD Checklist score [ Time Frame: Baseline, Week 8 ]
- Change in life functional capacity and quality of life scales [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335217
|United States, California|
|Semel Institute for Neuroscience and Human Behavior at UCLA|
|Los Angeles, California, United States, 90024|
|Principal Investigator:||Ian A Cook, M.D.||Semel Institute for Neuroscience and Human Behavior|