Clinical trial NCT04872465: TBS Over DLPFC in Elderly Refractory Depression
Official title: Efficacy of Bilateral Dorsolateral Prefrontal Theta-burst Stimulation in Elderly Refractory Depression: a Randomized Sham-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depression
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Hamilton Depression Rating Scale, HAM-D
timeFrame: Change from baseline after 1, 2 weeks and three months
Secondary outcomes:
measure: Beck depression inventory, BDI-II
timeFrame: Change from baseline after 1, 2 weeks and three months
measure: Beck anxiety inventory, BAI
timeFrame: Change from baseline after 1, 2 weeks and three months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Psychiatry, Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Che-Sheng Chu, MD
role: PRINCIPAL_INVESTIGATOR
References: