Intermittent Theta Burst Stimulation on Anhedonia in Depression

NCT06552026 | Completed DMC FDA Device

• 1 other identifier: Y&F
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Electroencephalography; Transcranial Magnetic Stimulation

Keywords

anhedonia; intermittent theta burst stimulation

Outcome Measures

Primary Outcomes (2)

• Change in depression symptoms severity

  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.

  Baseline;15 days after treatment

• Change from baseline in Motivation and Pleasure Scale

  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.

  Baseline;15 days after treatment

Secondary Outcomes (1)

• The alteration from baseline in electrophysiological source imaging results in multimodalities

  Baseline;15 days after treatment

Study Arms (2)

iTBS stimulation

EXPERIMENTAL

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.

Device: repeated transcranial magnetic stimulation

10 Hz-rTMS stimulation

ACTIVE COMPARATOR

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.

Device: repeated transcranial magnetic stimulation

Interventions

repeated transcranial magnetic stimulation DEVICE

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

10 Hz-rTMS stimulation; iTBS stimulation

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Depression; Anhedonia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kai Wang, PHD

  Anhui Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 13, 2024
• Study Start: August 12, 2020
• Primary Completion: October 10, 2022
• Study Completion: December 14, 2022
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

CN (1)