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In-patient SCC TMS

Primary Purpose

Major Depressive Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open-label TMS
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

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

Inclusion Criteria: All subjects must be between 18-65 years of age. Must have confirmed diagnosis of moderate to severe Major Depressive Disorder (single or recurrent episode) as defined by a HAM-D score of 17 or higher. Failure to respond to a minimum of 2 trials of antidepressant medication Failure to respond from at least two different agent classes Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count). Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration. Subjects are willing and able to adhere to the accelerated treatment schedule. Exclusion Criteria: Are mentally or legally incapacitated, unable to give informed consent Have an infection or poor skin condition over the scalp where the device will be positioned Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode. Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system. Presence of an implanted magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents. (Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation and MRI.)

Sites / Locations

  • UCLA TMS Service and Research Service

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label TMS

Arm Description

Outcomes

Primary Outcome Measures

Treatment Efficacy as Measured by Change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Final Visit
Treatment efficacy as measured by change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 84. Higher scores indicate a worse outcome and lower scores indicate better outcome.

Secondary Outcome Measures

Treatment Efficacy as Measured by Change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit.
Treatment efficacy as measured by change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit. This is a 9-item questionnaire with minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome.

Full Information

First Posted
December 1, 2022
Last Updated
May 8, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05645575
Brief Title
In-patient SCC TMS
Official Title
Pilot Study: Evaluating the Feasibility of Accelerated rTMS Treatment Delivered at Individual Resonant Frequencies for In-patient Subjects Suffering From Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 22, 2023 (Actual)
Primary Completion Date
February 22, 2025 (Anticipated)
Study Completion Date
February 22, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Participants will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 participants who will undergo up to three brain activity recordings, one MRI scan, one TMS procedure to determine the appropriate frequency and intensity for treatment, daily symptom assessments, and 25 TMS treatments. Participants will be asked to participate for up to 2 weeks.
Detailed Description
Repetitive Transcranial Magnetic Stimulation (rTMS) is an efficacious treatment for Major Depressive Disorder (MDD) and may hold therapeutic potential for suicidality, specifically. The clinical benefit of rTMS is thought to depend upon successful engagement of brain functional networks, which in turn depends on the preferred oscillatory frequency of the target network for that individual. The investigators have developed a novel interrogation method to identify the optimal individual stimulation frequency for each participant to enhance treatment response by maximizing the engagement of the functional brain networks. Our data suggest that stimulation at individualized frequencies results in about 50% better response for depression compared to the standard treatment of 10 Hz stimulation. Additionally, an accelerated administration of rTMS (a-rTMS) has been shown safe and tolerable, which is highly desirable in the context of a hospitalization. The investigators propose to use this approach to administer 25 sessions of individualized a-rTMS left dorsolateral prefrontal cortex (DLPFC) over a course of five days to obtain an accelerated relief of depression symptoms and reduce suicide risk. The investigators will enroll 30 in-patients undergoing treatment in the Resnick Neuropsychiatric Hospital. Patients will first undergo a brief (10-15 min) magnetic resonance imaging (MRI) for the purpose of neuronavigation to the optimal anatomical site. Subsequently, a motor threshold will be identified to determine the optimal stimulation intensity. Patients will receive 5 a-rTMS sessions daily for five days with a minimum interval of 1 hour between sessions. In addition to establishing tolerability and acceptability of the intervention, the goal is to evaluate the preliminary efficacy for improving depressive and suicidality symptoms. The investigators expect the treatment to be well tolerated, providing fast relief of depression and suicidal symptoms.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open-label Transcranial Magnetic Stimulation Treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-label TMS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Open-label TMS
Other Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Customized, Open-Label Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
Treatment Efficacy as Measured by Change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Final Visit
Description
Treatment efficacy as measured by change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 84. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Time Frame
2 Weeks (Baseline and Final Visit)
Secondary Outcome Measure Information:
Title
Treatment Efficacy as Measured by Change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit.
Description
Treatment efficacy as measured by change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit. This is a 9-item questionnaire with minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Time Frame
2 Weeks (Baseline and Final Visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects must be between 18-65 years of age. Must have confirmed diagnosis of moderate to severe Major Depressive Disorder (single or recurrent episode) as defined by a HAM-D score of 17 or higher. Failure to respond to a minimum of 2 trials of antidepressant medication Failure to respond from at least two different agent classes Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count). Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration. Subjects are willing and able to adhere to the accelerated treatment schedule. Exclusion Criteria: Are mentally or legally incapacitated, unable to give informed consent Have an infection or poor skin condition over the scalp where the device will be positioned Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode. Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system. Presence of an implanted magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents. (Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation and MRI.)
Facility Information:
Facility Name
UCLA TMS Service and Research Service
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing is dependent on request by other researchers and relation to study condition and treatment. De-identified study data will be shared at the PI's discretion.

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In-patient SCC TMS

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