Clinical trial NCT06552026: Intermittent Theta Burst Stimulation on Anhedonia in Depression
Official title: Intermittent Theta Burst Stimulation on Anhedonia of Treatment Resistant Depression and Brian Network Mechanism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Electroencephalography
Transcranial Magnetic Stimulation
Keywords: anhedonia; intermittent theta burst stimulation
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 33
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a parallel two-arm model ,Participants were randomized to two groups by coin toss, and delivered rTMS or iTBS over the lDLPFC-NAcc once daily for 15 consecutive days.
Primary purpose: TREATMENT

Brief summary: Study comparing the efficacy of two TMS patterns (intermittent theta-burst stimulation, iTBS, and repetitive transcranial magnetic stimulation, rTMS) in treating anhedonia and their associated brain network mechanisms.

Detailed description: Anhedonia is a core feature in major depressive disorders, severely affecting up to 70% patients and remaining untreated after traditional antidepressants therapies. In previous work, the investigators provided clinical evidence for the therapeutic efficacy of personalized rTMS in treating anhedonia. However, the key practical question is whether personalized, connectivity-guided iTBS performs comparably to the existing standard rTMS about the clinical efficacy.

This study was designed as a double-blind controlled trial to investigate the intervention effect of iTBS stimulation on anhedonia in depressed patients. 33 subjects were included, 17 participated in conventional 10 Hz-rTMS treatment and 16 in iTBS treatment. Using the subjects' MRI imaging data of the nucleus accumbens (NAcc) as a seed point, individualized left dorsolateral prefrontal cortex (lDLPFC) targets were calculated from brain imaging data. Patients received once-daily treatment for 15 days.

Clinical symptoms, behavioral and EEG assessments were performed before and after treatment. Clinical assessments included The Hamilton Anxiety Scale (HAMA), the Hamilton Depression Rating Scale (HAMD), the Beck Depression Inventory (BDI), the Temporal Experience of Pleasure Scale (TEPS), and Apathy Evaluation Scale (AES); behavioral and EEG data were collected by the Monetary paradigm. One month after the end of the intervention, follow-up BDI, TEPS, and AES symptom data were collected by electronic scales. This study focused on the analysis of scale, behavioral, and EEG data of subjects .

Eligibility criteria: Inclusion Criteria:

diagnosed by more than two clinical psychiatrists, using the DSM-5 diagnostic criteria for depression.

the Self-Report Apathy Evaluation Scale score was more than 37 and the The Temporal Experience of Pleasure Scale score was less than 76.

consistent medical therapeutic plan for ≥4 weeks or no history of antidepressant drugs before rTMS treatment.

aged between 16 and 50 years old.

Exclusion Criteria:

participants with unstable physical conditions, pregnancy or those that were breastfeeding.

metal implants on or inside the head. increased intracranial pressure from cerebral infarction or brain injury. a history of substance abuse or major psychiatric diseases other than depression and current use of psychoactive drug.

Primary outcomes:
measure: Change in depression symptoms severity
timeFrame: Baseline;15 days after treatment
measure: Change from baseline in Motivation and Pleasure Scale
timeFrame: Baseline;15 days after treatment
Secondary outcomes:
measure: The alteration from baseline in electrophysiological source imaging results in multimodalities
timeFrame: Baseline;15 days after treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Kai Wang, PHD
role: STUDY_CHAIR
References: