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iTBS Study for Depression (Randomized) | Clinical Trials | Clareo Health

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iTBS Study for Depression (Randomized)

Intermittent Theta Burst Stimulation to Relieve Depression and Concurrent Executive Function Impairment in Older Adults: A Randomized Controlled Study

NCT03745768•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

Executive function deficits are common in late life depression (LLD) and are associated with resistance to antidepressants, poor quality of life, considerable disability and increased suicidal risk. This study uses a novel type of Transcranial Magnetic Stimulation called intermittent Theta Burst Stimulation (iTBS). iTBS delivers high frequency (50Hz) magnetic pulses in "bursts" of 3 stimuli. It is posited that this intervention induces plasticity in the human cortex. Theoretical and empirical evidence from research studies informs that iTBS can improve depression and executive deficits, however, this has not been examined in older adults. This project examines iTBS's ability to improve depression and executive impairment in LLD. It also tests the effects of iTBS on brain connectivity within the Cognitive Control Network (CCN). This study will enhance understanding of LLD, providing critical pilot data to develop future randomized controlled clinical trials. Both active and sham interventions are administered sequentially to the left and right dorso-lateral prefrontal cortex. The total stimulation time is about 7 minutes. These interventions are administered for 6 weeks (Monday-Friday). 20 subjects will be randomized. Changes in mood from baseline to the end of study are measured with the Montgomery-Asberg Depression Rating Scale. Executive function at baseline and end of study are evaluated with the National Institutes of Health Toolbox executive domain battery. Safety assessments include: the 21 item Scale for suicidal ideation SSI. The frequency, intensity and burden of side effects rating (FIBSER) and the Altman Self Rating Mania scale (ASRM). Ancillary depression measures include the Quick Inventory of Depressive Symptoms (QIDS) and the Clinical Global Impression of Improvement scale. Subjects undergo functional Magnetic Resonance Imaging (fMRI) before and after the study interventions to test the effects of iTBS on the brain's functional connectivity. This research will provide meaningful information about the effects of iTBS on mood and executive function in older adults as well as information regarding its effects on brain function. Results of this pilot study will inform a grant submission and allow investigators to calculate power for a definitive randomized controlled clinical trial to test the efficacy of iTBS versus placebo.

Eligibility

Age

60 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age ≥ 60 - 85 years old
•2. Diagnosis of major depressive disorder (MDD), single or recurrent, with a current Major depression episode as diagnosed by the Mini-international Neuropsychiatric Interview (MINI 6.0)
•3. Montgomery Asberg Depression Scale score greater than or equal to 15 at baseline.
•4. Evidence of decreased executive function as evidenced by either of the following conditions: a) scoring below the mean normative scaled score on the average of the NIH Toolbox executive function measures: Flanker inhibitory control and attention test and the Dimensional sort card test, approximate score 70 - 100 as per PI discretion. b) Discrepancy of at least 10 points between the average of the picture vocabulary score and the reading recognition test score and the average of the Flanker inhibitory control and dimensional card sort test score. c) Frontal Systems Behavior Scale (FRSBE) T scores above 60 (indicative of borderline to clinically significant impairment) and at least 10 points (1 Standard Deviation) above subject's premorbid (pre-depression) scores.

Exclusion Criteria

•1. Inability to complete NIH tool box cognitive testing
•2. Inability to provide informed consent
•3. \<22 score on the Montreal Cognitive Assessment MoCA indicative of moderate to severe cognitive impairment per PI discretion
•4. Lifetime diagnosis of bipolar I or II disorder or psychotic disorder as per the MINI interview
•5. current psychotic symptoms
•6. alcohol or other substance use disorder per DSM V criteria in the past 6 months
•7. High risk for suicide (active suicidal ideation/intent or plan and patient is unsafe to be in the outpatient setting), an urgent psychiatric referral will be made in those cases
•8. Have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), assessed by a study investigator to be primary
•9. Previous history of TMS
•10. history of failure to an adequate course of electroconvulsive therapy (ECT) such as equal or more than 7-9 electroconvulsive therapy treatments, per PI discretion
+8 more criteria

Locations (1)

Washington University in St. Louis School of Medicine - Healthy Mind Lab

St Louis, Missouri, United States

Key Dates

Start Date

April 5, 2018

Primary Completion Date

April 1, 2020

Completion Date

April 1, 2020

Last Updated

July 6, 2022

Enrollment

ACTUAL participants

Conditions

Executive DysfunctionDepression

Interventions

Intermittent Theta Burst Stimulation

DEVICE

sham stimulation

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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iTBS Study for Depression (Randomized)

Inclusion Criteria

Exclusion Criteria

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