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TBS Over DLPFC in Elderly Refractory Depression

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ClinicalTrials.gov Identifier: NCT04872465
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : January 17, 2023
Sponsor:
Information provided by (Responsible Party):
Che-Sheng Chu, Kaohsiung Veterans General Hospital.

Study Description
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Brief Summary:
The study aim to examine the effect of Thea-burst stimulation over bilateral dorsolateral prefrontal cortex (DLPFC) among patients with LLD on mood condition and relevant biomarkers.

Condition or disease Intervention/treatment Phase
Major Depression Device: TBS Device: sham Not Applicable

Detailed Description:
Thea-burst stimulation (TBS) is a novel form of rTMS, providing greater modulation effect on neural activity. So far, no study was conducted to use TBS as treatment in LLD. Therefore, we aim to examine the effect of TBS over bilateral dorsolateral prefrontal cortex (DLPFC) among patients with LLD on mood condition and relevant biomarkers. The study used a two-arm, parallel, double-blind, randomized, and sham-controlled design. We plan to enroll sixty patients with LLD, thirty for active intervention and thirty for sham-controlled group. An Magstim Rapid2 stimulator with eight-figure coil was used for stimulation. Location of brain area are based on bilateral DLPFC. 3-pulse 50-Hz bursts was given every 200ms (at 5 Hz) and an intensity of 80% active motor threshold was settled. We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses). Each patient received daily stimulation for two weeks with total ten sessions. The primary outcomes were change of depression severity including response and remission rate. Secondary outcome were biomarkers related to depression. Assessments were administered at baseline, immediately after 5 and 10 sessions of stimulation, and 3 months after the completion of stimulation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Bilateral Dorsolateral Prefrontal Theta-burst Stimulation in Elderly Refractory Depression: a Randomized Sham-controlled Study
Actual Study Start Date : July 6, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Experimental
We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).
 Device: TBS
We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).
Placebo Comparator: Sham Comparator
Participants will receive sham (placebo) TBS treatment the same as experimental group
 Device: sham
Participants will receive sham (placebo) TBS treatment the same as experimental group


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Depression Rating Scale, HAM-D [ Time Frame: Change from baseline after 1, 2 weeks and three months ]
    The Ham-D is the most widely used clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.


Secondary Outcome Measures :
  1. Beck depression inventory, BDI-II [ Time Frame: Change from baseline after 1, 2 weeks and three months ]
    The BDI-II was a 1996 revision of the BDI. Participants were asked to rate how they have been feeling for the past two weeks. BDI-II also contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.

  2. Beck anxiety inventory, BAI [ Time Frame: Change from baseline after 1, 2 weeks and three months ]
    The BAI, created by Aaron T. Beck and other colleagues, is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are as follows: 0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; 26-63: severe anxiety.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 60 to 85 years
  • Major depression disorder
  • Under a stable dose of all psychotropic medication during the stimulation period.

Exclusion Criteria

  • Having any current psychiatric comorbidity or history of substance dependence.
  • Having active suicidal ideation currently.
  • Having severe physical illness, recent and/or current unstable medical disorders.
  • Having history of cancer or chemotherapy.
  • Dementia or MMSE<24.
  • Having TMS contraindicated (seizure disorder, history of seizures, metal in the head, pacemakers, history of craniotomy)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872465


Contacts
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Contact: Che-Sheng Chu, MD +886-7-3422121 ext 72068 cschu@vghks.gov.tw

Locations
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Taiwan
Department of Psychiatry, Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Che-Sheng Chu, MD    +886-7-3422121 ext 72068    cschu@vghks.gov.tw   
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Principal Investigator: Che-Sheng Chu, MD Kaohsiung Veterans General Hospital.
More Information
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Responsible Party: Che-Sheng Chu, Department of Psychiatry, MD, attending physician, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT04872465    
Other Study ID Numbers: Kaohsiung VGHKS
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: January 17, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
 Behavioral Symptoms
Mood Disorders
Mental Disorders