Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression

Sponsor
Jakub Antczak
Study ID
NCT06363981
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Active rTMS over the left DLPFC and over the left DMPFC — DEVICE
    Active rTMS over the left DLPFC and over the left DMPFC to induce the long term potentiation of stimulated areas.
  • Active rTMS over the left DLPFC — DEVICE
    Active rTMS over the left DLPFC to induce the long term potentiation of stimulated area.
  • Sham rTMS — DEVICE
    Sham rTMS over the left DLPFC or over the left DLPFC and over the left DMPFC for placebo.

Study Details

Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression.

Key Dates

First listed
Apr 12, 2024
Start date
May 20, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: rTMS over the left DLPFC and over the left DMPFC
    Active 10 Herz rTMS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus and the right abductor hallucis will be administered over the left DLPFC and over the left DMPFC respectively. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session ca 1500 magnetic pulses over the left DLPFC and ca 1500 over the left DMPFC will be elicited.
  • Active Comparator: rTMS over the left DLPFC
    Active 10 Herz rTMS 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 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session 3000 magnetic pulses over the left DLPFC will be elicited.
  • Sham Comparator: Sham rTMS
    Sham 10 Herz rTMS will be administered over the left DLPFC. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session 3000 magnetic pulses over the left DLPFC or ca 1500 magnetic pulses over the left DLPFC and ca 1500 over the left DMPFC will be elicited. (rTMS protocol will be chosen randomly before the first session).

Primary Outcome Measure

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

Central Contacts

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