NCT06552026

Intermittent Theta Burst Stimulation on Anhedonia in Depression

Intermittent Theta Burst Stimulation on Anhedonia of Treatment Resistant Depression and Brian Network Mechanism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Depression
• Electroencephalography
• Transcranial Magnetic Stimulation

Interventions

Type	Name	Description
DEVICE	repeated transcranial magnetic stimulation	repetitive transcranial magnetic stimulation by use of high-frequency (10 Hz) left-side DLPFC stimulation is currently widely used in the treatment of depression17.Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered with shorter duration of stimulation sessions and apparent efficacy at lower stimulation intensities18. Both 10 Hz and intermittent theta burst stimulation pulses have an excitatory effect on cortical excitability

Timeline

• Start date: 2020-08-12
• Primary completion: 2022-10-10
• Completion: 2022-12-14
• First posted: 2024-08-13
• Last updated: 2024-08-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study