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

NCT06363981 | Recruiting

• 1 other identifier: JagiellonianU72
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unipolar Depression; Bipolar Disorder

Keywords

depression; repetitive transcranial magnetic stimulation; dorsolateral prefrontal cortex; dorsomedial prefrontal cortex; cognitive impairment; anhedonia; sleep disorders

Outcome Measures

Primary Outcomes (3)

• Beck Depression Inventory 2

  Inventory consisting of 21 items measuring cognitive, affective, somatic, and vegetative symptoms of depression. Each item is scored from 0 to 3, with a higher score denoting more severe depression. Items are related to the criteria from the Diagnostic and Statistical Manual of Mental Disorders-IV. The minimum value of the total score is 0 and the maximum is 63 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

  Before intervention - four weeks after finishing intervention.

• Froward digit span

  A measure of verbal short term and working memory. Participant is asked to repeat the random series of numbers, which become longer along with every correctly repeated one. Test is finished after participant failed to respond correctly on three occasions. The number of correctly repeated series determines the final score, which is an integer representing the length of the largest passed sequence. The scores range from 3 to 9 with higher scores denoting better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

  Before intervention - four weeks after finishing intervention.

• Language part of Addenbrooke's Cognitive Examination

  A test to identify cognitive impairment in dementia. In the language part, participant is asked to complete a set commands such as "place the paper on top of the pencil"; to write grammatically-complete sentences; to repeat several words and proverbs; to name the objects shown in drawings, and answer questions and to read several mispronounced words. The number of correctly completed tasks is scored. The minimum value of the total score is 0 and the maximum (of the language part) is 26 with higher scores meaning better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

  Before intervention - four weeks after finishing intervention.

Secondary Outcomes (4)

• Dimensional Anhedonia Rating Scale

  Before intervention - four weeks after finishing intervention.

• Athens Insomnia Scale

  Before intervention - four weeks after finishing intervention.

• Pittsburgh Sleep Quality Index

  Before intervention - four weeks after finishing intervention.

• Epworth Sleepiness Scale

  Before intervention - four weeks after finishing intervention.

Study Arms (3)

rTMS over the left DLPFC and over the left DMPFC

EXPERIMENTAL

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.

Device: Active rTMS over the left DLPFC and over the left DMPFC

rTMS over the left DLPFC

ACTIVE COMPARATOR

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.

Device: Active rTMS over the left DLPFC

Sham rTMS

SHAM COMPARATOR

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).

Device: Sham rTMS

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.

rTMS over the left DLPFC and over the left DMPFC

Active rTMS over the left DLPFC DEVICE

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

rTMS over the left DLPFC

Sham rTMS DEVICE

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

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy

Sponsors & Collaborators

• Jakub Antczak: lead
• Andrzej Frycz Modrzewski Krakow University: collaborator

Study Sites (1)

The Education of Research and Development Center, Babinski Clinical Hospital

Krakow, 30393, Poland

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder; Depression; Cognitive Dysfunction; Anhedonia; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wojciech Korzeniowski, MD

  The Education of Research and Development Center, Babinski Clinical Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wojciech Korzeniowski, MD

CONTACT

+48 12 652 45 20; wojciech.korzen@gmail.com

Jakub Antczak, MD

CONTACT

+48 12 400 25 50; jakub.antczak@uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

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

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: December 2026 - December 2030
• Access Criteria: For researchers in medical sciences and medical professional upon justification of their request.

Locations

PL (1)