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Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

NCT06371352 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-10-15

No results posted yet for this study

Summary

Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.

Conditions

Interventions

DEVICE

iTBS

Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.

DEVICE

cTBS

Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.

DEVICE

Sham

Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.

Sponsors & Collaborators

  • Institute of Psychiatry and Neurology, Warsaw

    collaborator OTHER

  • Jakub Antczak

    lead OTHER

Principal Investigators

  • Bogdan Stefanowski, MD · Institute of Psychiatry and Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371352 on ClinicalTrials.gov