Depression, Electroencephalography, Transcranial Magnetic Stimulation
Conditions
Keywords
anhedonia; intermittent theta burst stimulation
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 .
Interventions
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
Sponsors
Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
In this clinical trial, a double-blind design will be implemented. Neither the participants nor the researchers conducting the trial will be aware of the specific objectives or the allocation of treatment conditions. This approach is intended to eliminate bias and ensure the integrity of the study's outcomes.
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed