Combining rTMS and tDCS in Depression: an Exploratory Clinical Trial

NCT ID: NCT06500533

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-05-19

Brief 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

Major Depression; Treatment Resistant Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study's single arm

Patients will be receiving rTMS/tDCS combined 30-session protocol, consisting of 15 rTMS sessions every other day alternating with 15 tDCS at-home treatments.

The rTMS protocol used in the study will be intermittent Theta Burst Stimulation (iTBS) on the left dorsolateral prefrontal cortex given for 3 minutes and 9 seconds, every other day 5 weeks. iTBS is delivered in 2s bursts consisting of three pulses at a frequency of 50 Hz, with an inter-burst interval of 200 ms (i.e., 5 Hz). Stimulation intensity will be 120% of resting motor threshold.

Each of the 15 tDCS sessions will be lasting 30 minutes with a stimulation intensity of 2mA. The electrodes will be positioned bilaterally over the dorsolateral prefrontal cortex. The device chosen for the study is specifically designed for home use. The device is controlled via an app that walks the participant through correct usage and dosage with the device to minimize non-compliance.

Group Type: EXPERIMENTAL

rTMS combined with tDCS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female, between 22 and 80 years of age.
• Able to provide informed consent.
• Primary diagnosis of depressive episode (F32) or recurrent depressive disorder (F33), according to International Classification of Diseases 10th Revision (ICD-10).
• Simultaneous fulfillment of diagnostic criteria for Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE), according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• Currently experiencing moderate to severe depressive episodes (scores ≥20 on the 17-item Hamilton Depression Rating Scale [HAM-D 17]).

Exclusion Criteria

• Primary psychiatric diagnosis other than single episode depressive disorder or recurrent depressive disorder.
• History of schizophrenia or schizoaffective disorders.
• Any history of psychotic symptoms in the current or previous depressive episodes.
• History of obsessive-compulsive disorder.
• History of autism spectrum disorder.
• History of intractable migraine.
• Clinical conditions that would increase risks associated with receiving high-dose iTBS.
• Cochlear implants.
• Epilepsy.
• Pacemakers.
• Presence of metal in the head, especially of a ferromagnetic type.
• Presence of magnetically controlled implantable devices.
• Current drug misuse (F10-F19).
• History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
• Current (or chronic) use of opiates.
• Prior nonresponse to rTMS.
• Prior nonresponse to Electroconvulsive Therapy (ECT).
• Female that is pregnant or breastfeeding.
• Female with a positive pregnancy test at participation.
• History of psychosurgery for depression.
• Damage to- or diseases of the skin, which affects the scalp. E.g. Psoriasis or open wounds.
• No changes in psychotropic medication during the study will be allowed, with the exception of the ones due to intolerability.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regionspsykiatrien Gødstrup

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro C Barata, MD

Role: PRINCIPAL_INVESTIGATOR

Regionspsykiatrien Gødstrup

Locations

Regionspsykiatrien Gødstrup

Herning, Central Jutland, Denmark

Countries

Denmark

Other Identifiers

Open label TMS

Identifier Type: -

Identifier Source: org_study_id