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

Sponsor
Jakub Antczak
Study ID
NCT06371352
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • iTBS — DEVICE
    Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.
  • cTBS — DEVICE
    Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.
  • Sham — DEVICE
    Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.

Study Details

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.

Key Dates

First listed
Apr 17, 2024
Start date
May 15, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: iTBS over the left DLPFC
    Active iTBS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus will be administered over the left DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 magnetic pulses will be elicited.
  • Experimental: cTBS over the right DLPFC
    Active cTBS with intensity of 120% of the resting motor threshold recorded from the left first dorsal interosseus will be administered over the right DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 1200 magnetic pulses will be elicited.
  • Sham Comparator: Sham stimulation
    Active iTBS or cTBS will be administered over the left or right DLPFC respectively with sham coil. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 or 1200 magnetic pulses will be elicited.

Primary Outcome Measure

Beck Depression Inventory 2 [ Time Frame: Before intervention - four weeks after finishing intervention. ]

Central Contacts

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