Back to results

Trigeminal Nerve Stimulation for Depression: Dose Finding

Primary Purpose

Depression

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Trigeminal Nerve Stimulation

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Major Depressive Disorder (MDD), EEG, Trigeminal Nerve Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the MINI structured interview
A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
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)
Age range: 18 to 65 years old.
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

Patient is mentally or legally incapacitated, unable to give informed consent.
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); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
Patients with exposure to ECT or VNS within the past 6 months.
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.
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.
Other medical contraindications to any of the study procedures

Sites / Locations

Semel Institute for Neuroscience and Human Behavior at UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Low frequency to High

High frequency

Arm Description

For the first six weeks, subjects randomized to this group will receive low frequency stimulation. At the six week point, the low frequency group subjects will be crossed over to high frequency for the remaining six weeks.

Subjects randomized to this group will receive high frequency stimulation for the entire 12 weeks of the first phase of this study.

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Rating Scale 17 score

Secondary Outcome Measures

Change in life functional capacity and quality of life scales

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 Regional Brain Function

As measured by qualitative electroencephalographic (QEEG) recordings

Changes in vital signs recordings

Autonomic function (i.e. pulse and blood pressure) are monitored for 30 mins of stimulation at baseline, week 6, and week 12. Resting vital signs are recorded for each visit.

Changes in Safety Assessment Measures

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)

Full Information

NCT ID

NCT01343563

First Posted

April 5, 2011

Last Updated

February 4, 2013

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT01343563

Brief Title

Trigeminal Nerve Stimulation for Depression: Dose Finding

Official Title

Trigeminal Nerve Stimulation for Depression: Dose Finding

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Depression, Major Depressive Disorder (MDD), EEG, Trigeminal Nerve Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low frequency to High

Arm Type

Active Comparator

Arm Description

Arm Title

High frequency

Arm Type

Active Comparator

Arm Description

Subjects randomized to this group will receive high frequency stimulation for the entire 12 weeks of the first phase of this study.

Intervention Type

Procedure

Intervention Name(s)

Trigeminal Nerve Stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Hamilton Depression Rating Scale 17 score

Time Frame

baseline, week 6, week 12

Secondary Outcome Measure Information:

Title

Change in life functional capacity and quality of life scales

Description

Life functional capacity and quality of life scales include: Short-form Health Survey-36 Item and Quality of Life Enjoyment and Satisfaction Questionnaire

Time Frame

baseline, week 6, week 12

Title

Changes in Regional Brain Function

Description

As measured by qualitative electroencephalographic (QEEG) recordings

Time Frame

baseline, week 6, week 12

Title

Changes in vital signs recordings

Description

Autonomic function (i.e. pulse and blood pressure) are monitored for 30 mins of stimulation at baseline, week 6, and week 12. Resting vital signs are recorded for each visit.

Time Frame

At every visit for 12 weeks

Title

Changes in Safety Assessment Measures

Description

Time Frame

At every visit for 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the MINI structured interview A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2 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) Age range: 18 to 65 years old. 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 Patient is mentally or legally incapacitated, unable to give informed consent. 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); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded. Patients with exposure to ECT or VNS within the past 6 months. 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. 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. Other medical contraindications to any of the study procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian A Cook, MD

Organizational Affiliation

Semel Institute for Neuroscience and Human Behavior

Official's Role

Principal Investigator

Facility Information:

Facility Name

Semel Institute for Neuroscience and Human Behavior at UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Trigeminal Nerve Stimulation for Depression: Dose Finding

We'll reach out to this number within 24 hrs