RecruitingNot ApplicableNCT06323486

Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression

Effects of Accelerated Bilateral Sequential Theta Burst Stimulation on Dual-task Cost, Depression, Cognition and Other Outcomes in Older Adults With Treatment-resistant Depression: A Randomized, Double-blind, Sham-controlled Trial

Sponsor

Ontario Shores Centre for Mental Health Sciences

Enrollment

54 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Depressive Disorder, Treatment-Resistant

Summary

The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future.

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an accelerated form of brain stimulation therapy — called theta burst stimulation (TBS) — delivered to both sides of the brain in quick succession for older adults with treatment-resistant depression. This is a non-invasive procedure using magnetic pulses to stimulate specific brain areas. **You may be eligible if:** - You are 50 years or older - You have been diagnosed with major depressive disorder (non-psychotic) - You are currently in a depressive episode with a Hamilton Depression Score of 17 or higher - You have not responded to at least 2 adequate courses of antidepressant medications during this episode - If you are taking psychiatric medications, you have been on a stable dose for at least 1 week **You may NOT be eligible if:** - You have bipolar disorder or a history of psychosis - You have a history of seizures or a brain implant (e.g., pacemaker, metal in the head) - You are actively suicidal - You have severe cognitive decline or dementia - You are currently pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEactive accelerated bilateral sequential theta burst stimulation and sham treatment

We shall use the Magpro device (Magventure) employing the specialized Active/Sham B70 coil. absTBS shall be administered consisting of 6 sessions daily (with a 50-minute interval between treatment sessions) on Mondays to Fridays or for a maximum of 5 working days of daily treatment. The target stimulation intensity will be set at 90 to 120% of the subject's resting motor threshold (RMT). Each session shall be composed of administration of continuous theta burst stimulation (triplet burst pulses at 50 Hz, repeated at 5 Hz, for a total of 600 pulses per session over 40 seconds administered on the right dorsolateral prefrontal cortex) and then intermittent theta burst stimulation (triplet burst pulses at 50 Hz bursts, repeated at 5 Hz, 2 s on and 8 s off, for a total of 600 pulses per session over about 3 min, administered on the left dorsolateral prefrontal cortex). The sham treatment will be conducted for the same number of sessions and duration as the absTBS treatment sessions.