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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2027-04-30

Brief Summary

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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.

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Detailed Description

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Depression is one of the most common and disabling disorders, affecting approximately three hundred million people worldwide. Depressive mood is the main symptom, but other symptoms like cognitive impairment, anhedonia or sleep disorders contribute significantly to patients suffering, decrease quality of life and may even lead to suicide attempt. While modern pharmacotherapy can significantly improve symptoms in many patients, still one third of patients remains drug-resistant. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method of inducing brain plasticity. Stimulation over the left and right dorsolateral prefrontal cortex (DLPFC) and possibly over several other areas can improve mood. Only few studies investigated the effect of rTMS on negative psychiatric symptoms, such as anhedonia, sleeplessness or cognitive impairment. In these trials, either the DLPFC or the dorsomedial prefrontal cortex (dmPFC) were stimulated and sometimes other areas such as the insular cortex. The aim of this study is to investigate if a stimulation over both sites (multi-site stimulation) has better therapeutic potential for depressed mood, cognitive impairment, anhedonia and sleep disorders than stimulation over DLPFC alone and placebo.

Conditions

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Unipolar Depression Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Placebo intervention will be delivered with a programmable coil for magnetic stimulation, which can be switched by a third person between modes of active (therapeutic) and sham stimulation. In the sham-mode coil elicits similar sounds as in the active stimulation, but induces only negligible magnetic field.

Study Groups

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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.

Group Type EXPERIMENTAL

Active rTMS over the left DLPFC and over the left DMPFC

Intervention Type DEVICE

Active rTMS over the left DLPFC and over the left DMPFC to induce the long term potentiation of stimulated areas.

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.

Group Type ACTIVE_COMPARATOR

Active rTMS over the left DLPFC

Intervention Type DEVICE

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

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).

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type DEVICE

Sham rTMS over the left DLPFC or over the left DLPFC and over the left DMPFC for placebo.

Interventions

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Active rTMS over the left DLPFC and over the left DMPFC

Active rTMS over the left DLPFC and over the left DMPFC to induce the long term potentiation of stimulated areas.

Intervention Type DEVICE

Active rTMS over the left DLPFC

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

Intervention Type DEVICE

Sham rTMS

Sham rTMS over the left DLPFC or over the left DLPFC and over the left DMPFC for placebo.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
* Hamilton Depression Rating Scale between between 20 and 35 points at inclusion
* The score in the Athens Insomnia Scale eight or more
* The score of three or more points in items 4 and 21 of the Beck Depressions Inventory 2
* Complaining about problems with memory and concentration timely related with the onset of depression

Exclusion Criteria

* Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
* Psychotic symptoms at the time of inclusion
* Suicidal ideations and/or attempts within three months prior to inclusion

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No