Trigeminal Nerve Stimulation for Depression: Dose Finding
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in Hamilton Depression Rating Scale 17 score
Study Overview
Brief Summary
This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) when added onto antidepressant medications. Our primary objective is the examination of two different "doses" of TNS, in terms of pulse frequency.
To accomplish our specific aims, the investigators will test the following specific hypotheses:
- Subjects will show greater improvement in ratings of mood and other symptoms of depression during the six-week of high frequency stimulation than during low frequency stimulation periods.
- Subjects will show greater improvement after 12 weeks of high frequency stimulation than after six weeks of high frequency stimulation.
- 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.
- Subjects will show significant differences in regional brain function at the end of the high frequency stimulation period compared with baseline, and significant differences between high and low frequency stimulation conditions.
Detailed Description
A total of 20 subjects with Major Depressive Disorder (MDD), ages 18 to 65, will be consented and join this project at UCLA.
The project has two phases: a 12 week treatment phase and a 6 month follow-up phase. In the first phase, a double-blind one-way cross-over design will allow us to compare the clinical and physiologic responses to TNS at two frequencies of stimulation, "high" (~120 Hz) and "low " (~20 Hz). Subjects will be randomized to start a six week period at either high or low frequency stimulation (n=10 in each); both subjects and the staff who interact with them will be blinded to assignment, and a separate member of the team will program the device settings. At the six week point, the low frequency group subjects will be crossed over to high frequency, while the high frequency group will continue at high frequency. At the end of the 12 weeks, the TNS systems will be returned and the adjunctive treatment will end. All subjects will be followed for another six months with monthly telephone calls to monitor symptoms or changes in treatment that would signal a return of symptoms. The primary endpoint is the change in depression severity for the two groups at the week 6 visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Hamilton Depression Rating Scale 17 score
Time Frame: baseline, week 6, week 12
Secondary Outcomes
- Change in life functional capacity and quality of life scales(baseline, week 6, week 12)
- Changes in Regional Brain Function(baseline, week 6, week 12)
- Changes in vital signs recordings(At every visit for 12 weeks)
- Changes in Safety Assessment Measures(At every visit for 12 weeks)
Investigators
Ian A. Cook, M.D.
Principal Investigator
University of California, Los Angeles