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Combined rTMS/tDCS in Unipolar Depression: an Exploratory Open-label Trial
The investigators aim to conduct a single-arm open-label clinical trial, meaning that the investigators will be administering a treatment protocol to one group of patients, where no information is withheld from trial participants. The treatment being researched will consist of a rTMS/tDCS combined 30-session protocol, consisting of 15 rTMS sessions every other day alternating with 15 tDCS at-home treatments. Treatment sessions will occur from Monday to Friday. rTMS (Repetitive Transcranial Magnetic Stimulation) is a non-invasive physical treatment, which uses pulsing magnetic fields to activate or suppress the brain centres associated with medical and psychiatric disorders, thus treating the brain circuits involved in the patient's condition. tDCS (transcranial direct current stimulation) is a form of neuromodulation that uses constant, low direct current delivered via electrodes on the head. The investigators aim to recruit 40 patients with difficult to treat unipolar depression. Patients will be selected among the referrals to the psychiatry department in Gødstrup and to the psychiatry department in Randers. rTMS treatment will be administered by the experienced nurses of the rTMS clinic of each department. The TMS treatment will profit from ongoing supervision by the Clinical Directors of each rTMS clinic. tDCS will be performed at home by the patients. The study itself will last 30 days per patient, where rTMS will be administered on odd numbered days (study day 1, 3, 5, 7, ..29) and tDCS on even numbered days (study day 2, 4, 6, 8, … 30). All patients will start with rTMS and finish with home-based tDCS treatment. Both rTMS and tDCS treatments will be administered during working days, from Monday to Friday. The trial itself is expected to last no more than two years. The goal of this study then is to examine the effectiveness of this combined neuromodulation intervention, which has the advantage of reducing the attendance requirements for TMS treatment by 50%.
Age
22 - 80 years
Sex
ALL
Healthy Volunteers
No
Regionspsykiatrien Gødstrup
Herning, Central Jutland, Denmark
Start Date
July 31, 2024
Primary Completion Date
May 19, 2025
Completion Date
May 19, 2025
Last Updated
May 23, 2025
7
ACTUAL participants
rTMS combined with tDCS
DEVICE
Lead Sponsor
Regionspsykiatrien Gødstrup
NCT04480918
NCT04041479
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03320304