Combining rTMS and tDCS in Depression: an Exploratory Clinical Trial
NCT Number: NCT06500533
Acronym: CombTMS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depression|Treatment Resistant Depression
Interventions: DEVICE: rTMS combined with tDCS
Sponsor: Regionspsykiatrien Gødstrup
Collaborators: Regionspsykiatrien Randers
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-07
Locations: Regionspsykiatrien Gødstrup, Herning, Central Jutland Region, 7400, Denmark|Regionspsykiatrien Randers, Randers, Central Jutland Region, 8930, Denmark

Summary:
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%.

Primary Outcome Measures: HAM-D17 scores, Our primary outcome measure will be Hamilton Depression Rating Scale, 17-item version (HAM-D17) scores at the end of the 30th treatment session and 4 weeks after the last treatment (study week 9), normalized to baseline. HAM-D17 scores will be used to calculate response and remission rates in each group:

* Response: reduction ≥50% in HAM-D17
* Remission: HAM-D17 scores ≤7, Baseline, end of the 30th treatment session and 4 weeks after the last treatment.
Secondary Outcome Measures: MDI-scores, Our secondary outcome will be changes in scores on the Major Depression Inventory (MDI) will be used as a secondary measure of depression severity (30th session; 4 weeks after the 30th session), normalized to baseline. MDI scores will be used to calculate response and remission rates in each group:

* Response: reduction ≥50% in MDI
* Remission: MDI scores ≤20, Baseline, end of the 30th treatment session and 4 weeks after the last treatment.