Intermittent Theta Burst Stimulation on Anhedonia in Depression

Not Applicable

Completed

• Conditions: Depression; Electroencephalography; Transcranial Magnetic Stimulation
• Interventions: Device: repeated transcranial magnetic stimulation

• Registration Number: NCT06552026
• Lead Sponsor: Anhui Medical University

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 .

Study Timeline

• Study Start: 2020-08-12
• Primary Completion: 2022-10-10
• Study Completion: 2022-12-14
• Study First Submitted: 2024-07-22
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-11
• Last Update Submitted: 2024-08-11
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iTBS stimulation	repeated transcranial magnetic stimulation	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.
10 Hz-rTMS stimulation	repeated transcranial magnetic stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change in depression symptoms severity	Baseline;15 days after treatment	The Hamilton depression rating scale-17 items (HAMD-17) to clinically assess severity of depression. The curative effects of the treatment were classified according to the reduction in HAMD. Response was defined as ≥50% symptom reduction from pre-to post-treatment with a HAMD score; remission criteria were set at a post-treatment score ≤7 for HAMD.
Change from baseline in Motivation and Pleasure Scale	Baseline;15 days after treatment	Change from baseline in Motivation and Pleasure Scale The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.

Secondary Outcome Measures

Name	Time	Method
The alteration from baseline in electrophysiological source imaging results in multimodalities	Baseline;15 days after treatment	The activation of nucleus accumbens, dorsal lateral prefrontal cortex and the functional connection these brain area assessed by source-level resting-state EEG connectivity in multimodalities change from baseline after the treatment.

Trial Locations

Locations (1)

Anhui Medical University; 🇨🇳 Hefei, Anhui, China