Efficacy of Bilateral Dorsolateral Prefrontal Theta-burst Stimulation in Elderly Refractory Depression: a Randomized Sham-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Hamilton Depression Rating Scale, HAM-D
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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<
- •Having TMS contraindicated (seizure disorder, history of seizures, metal in the head, pacemakers, history of craniotomy)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- Beck anxiety inventory, BAI(Change from baseline after 1, 2 weeks and three months)
- Beck depression inventory, BDI-II(Change from baseline after 1, 2 weeks and three months)
Investigators
Che-Sheng Chu
Department of Psychiatry, MD, attending physician
Kaohsiung Veterans General Hospital.