Multisite Repetitive Transcranial Magnetic Stimulation for Mood, Cognitive Impairment, Anhedonia and Disordered Sleep in Depressive Disorder
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Poland
The Education of Research and Development Center, Babinski Clinical Hospital
RECRUITING
Krakow
Contact Information
Primary
Wojciech Korzeniowski, MD
wojciech.korzen@gmail.com
+48 12 652 45 20
Backup
Jakub Antczak, MD
jakub.antczak@uj.edu.pl
+48 12 400 25 50
Time Frame
Start Date:2024-05-20
Estimated Completion Date:2027-04
Participants
Target number of participants:90
Treatments
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).