NQ TMS for MDD Therapy Using 1 Day x 3 Sessions Protocol for Adult Patient

NCT06772987 | Completed DMC FDA Device

• 2 other identifiers: CL-NQ-2024-01BRANY IRB File #24-02-624-1959
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial Magnetic Stimulation (TMS) Therapy is a non-invasive procedure that uses magnetic pulses to stimulate the cortex (brain) to treat Major Depressive Disorder (MDD). Currently established therapy uses one 19-minute treatment session per day for 5 days per week for 6 weeks, for a total of 30 treatment sessions. The goal of this clinical trial is to evaluate the safety and effectiveness of an accelerated but shortened TMS dosing regimen for adults with MDD aged 22-85. Participants in this study will be subjected to the same 19-minutes treatment session, but three times on the same day, and only for one day. This will greatly reduce the logistical burden of completing the therapy regime.

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder; Accelerated Treatment; 1-Day Treatment

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS) Score

  Change in MADRS score from baseline to immediately post treatment, 24 hours and 7 days post-treatment

  From enrollment to final MADRS score assessment within 2 weeks.

Secondary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9) Score

  From enrollment to final PHQ-9 score assessment within 2 weeks.

Study Arms (1)

Accelerated Protocol

EXPERIMENTAL

1 Day x 3 Sessions treatment protocol, with 60 minutes rest between sessions. Each session is a 19-minutes rTMS treatment.

Device: Accelerated rTMS treatment

Interventions

Accelerated rTMS treatment DEVICE

1 Day x 3 Sessions of 19-minutes rTMS treatment, with 60 minutes rest between sessions.

Accelerated Protocol

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 22-85.
• Current diagnosis of major depressive disorder according to the criteria defined in the current Diagnosis and Statistical Manual of Mental Disorders (DSM-V) without psychotic features.
• Failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
• MADRS score \> 20 at baseline and immediately prior to the day of treatment.
• Agrees to adhere to the study treatment and follow-up schedule.
• Willingness to remain on stable medications during rTMS therapy.
• Fluent in English.

You may not qualify if:

• Any medical conditions that would preclude the use of rTMS to treat depression.
• Any conditions that would prevent the ability to undergo MRI testing.
• Pregnancy as determined by serum/urine pregnancy test
• History of epilepsy, seizure(s), or a seizure disorder as determined by the principal investigator based on a medical history obtained from the patient and/or others authorized to provide such history, combined with a brief screening instrument.
• Active substance abuse
• Diagnosis of bipolar or psychotic disorder
• Considered to be at moderate-high risk of suicide according to the CSSRS assessment (i.e., Answers YES to Question 3 and NO to Question 6; or answers YES to Question 4, 5, or 6)
• As determined by the Principal Investigator, subjects with cognitive impairment according to either the medical history obtained from the patient and/or a reliable secondary source, or the results of the Montreal Cognitive Assessment (MoCA) performed during screening.

Sponsors & Collaborators

• NeuroQore Inc.: lead
• Makromed Inc.: collaborator

Study Sites (1)

LGTC Group

San Jose, California, 95124, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label study

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: January 16, 2025
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

US (1)