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Combining rTMS and tDCS in Depression: an Exploratory Clinical Trial

NCT06500533 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-05-23

No results posted yet for this study

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%.

Conditions

Interventions

DEVICE

rTMS combined with tDCS

The intervention 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 TMS and finish with home-based tDCS treatment. Both rTMS and tDCS treatments will be administered during working days, from Monday to Friday. rTMS treatment will be administered by the experienced nurses of the rTMS clinic of each department. The rTMS treatment will profit from ongoing supervision by the Clinical Directors of each TMS clinic, which is in line with treatment as usual. tDCS will be performed at home by the patients.

Sponsors & Collaborators

  • Regionspsykiatrien Gødstrup

    lead OTHER

Principal Investigators

  • Pedro C Barata, MD · Regionspsykiatrien Gødstrup

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-05-19
Completion
2025-05-19

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06500533 on ClinicalTrials.gov