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Trigeminal Nerve Stimulation for Depression: Dose Finding

NCT01343563 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-02-06

No results posted yet for this study

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:

1. 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.
2. Subjects will show greater improvement after 12 weeks of high frequency stimulation than after six weeks of high frequency stimulation.
3. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS.
4. Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
5. 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.

Conditions

Interventions

PROCEDURE

Trigeminal Nerve Stimulation

External trigeminal nerve stimulation (TNS) as an adjunctive treatment added onto antidepressant medications.

Sponsors & Collaborators

Principal Investigators

  • Ian A Cook, MD · Semel Institute for Neuroscience and Human Behavior

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01343563 on ClinicalTrials.gov