Intermittent Theta Burst Stimulation on Anhedonia in Depression

Anhui Medical University

Status: Completed

Conditions: Electroencephalography; Transcranial Magnetic Stimulation; Depression

Treatments: Device: repeated transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06552026

Y&F

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 33 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

iTBS stimulation

Experimental group

Description:

The iTBS stimulation lasted 3 min 9 s and delivered at triplet 50 Hz bursts, repeated at 5 Hz with 2s on, 8 s off, 600 pulses per session at 80% of the rest motor threshold(RMT) . Behavior and EEG dataset should be acquired before the first iTBS session and after the last iTBS session.

Treatment:

Device: repeated transcranial magnetic stimulation

10 Hz-rTMS stimulation

Active Comparator group

Description:

The rTMS stimulation lasted 25 mins and delivered at 10 Hz with 1s duration,4s rest, a total of 3000 pulses at 100% of the rest motor threshold(RMT) . Behavior and EEG dataset should be acquired before the first rTMS session and after the last rTMS session.

Treatment:

Device: repeated transcranial magnetic stimulation