Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression

NCT05172505 | Unknown

• 1 other identifier: HomeDC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive transcranial brain stimulation (NTBS) techniques are well established in experimental neuroscience and have been increasingly used in the treatment of mental illnesses, especially depressive disorders, in the last years. Transcranial direct current stimulation (tDCS) of prefrontal cortex regions has been reported to exert antidepressant effects. Treatment with tDCS for MDD requires sessions several times a week, which is very time-consuming and stressful for patients, as they have to come to the clinic almost every day. At the same time, the availability of non-drug therapies for MDD is limited, especially in more rural areas. The home-treatment approach with tDCS for MDD could address this problem and is of increasing interest in times of the Covid-19 pandemic, when frequent clinic visits should be avoided. There are some studies on the home-treatment approach with tDCS for different, mainly neurological disorders such as parkinson's disease, multiple sclerosis and chronic pain. For the treatment of MDD with tDCS in the home treatment setting, only one pilot study has been published so far, which shows good feasibility and good antidepressant effects. However, this study does not include a placebo condition. The study will be conducted in a double-blind, placebo-controlled, parallel-group design with 16 patients per group. Patients with MDD do a 6-weeks self-administered treatment with prefrontal tDCS (anode: F3, cathode: F4, 5 sessions/week, 30min/day, 2mA intensity) or sham tDCS (parameters correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation) as adjunctive treatment to a serotonergic medication or alone. For the continuous monitoring of the technical parameters and thus for quality control and for blinding, the same technical achievements as in the DepressionDC trial are used. As a new feature, a cap is used for easier handling in the home-treatment setting, in which electrodes are already integrated at the F3 and F4 points. This study aims to investigate the feasibility and effectiveness of 6 weeks of daily home treatment with tDCS for MDD. According to the DepressionDC trial, the primary outcome parameters are the decrease in the MADRS after 6 weeks and at the end of the follow-up phase, as well as the feasibility based on the dropout rates and the outcome in the comfort rating questionnaire. Additional baseline examinations with cMRI and e-field modelling will investigate the possible influence of the individual e-field on the outcome.

Conditions

Depression

Keywords

tDCS; Depression; Home Treatment

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Drop out rates, number of completed stimulation sessions in the treatment phase

  6 weeks

Secondary Outcomes (3)

• Safety

  6 weeks

• Change in BDI, GAF and CGI

  10 weeks

• Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline

  6 weeks

Study Arms (2)

Active prefrontal tDCS 2mA 6 weeks 5x/week

ACTIVE COMPARATOR

Device: prefrontal tDCS

Sham prefrontal tDCS 6 weeks 5x/week

SHAM COMPARATOR

Device: prefrontal tDCS

Interventions

prefrontal tDCS DEVICE

2 mA prefrontal tDCS (anode over F3, cathode over F4 10/20 EEG System) for 6 weeks, 5x/week in a home treatment Setting (self application) for 30 mins.

Active prefrontal tDCS 2mA 6 weeks 5x/week; Sham prefrontal tDCS 6 weeks 5x/week

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary DSM-5 diagnosis of Major Depression as assessed by the M.I.N.I with a single or recurrent episode with the additional requirements of a current episode with a duration of ≥4 weeks.
• Current depressive episode is less than 5 years duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-5 definition of major depressive episode).
• Total HDRS-21 ≥13 at the screening visit.
• Patient is taking one of the following antidepressants of adequate dose and ≥2 weeks in the current Episode: SSRIs: Escitalopram, Citalopram, Sertralin, Paroxetin, Fluoxetin, Fluvoxamin; SSNRIs: Duloxetin, Venlafaxin, Milnacipran. and optional concomitant treatment with Quetiapin, Lithium und Mirtazapin.
• Capable and willing to provide informed consent.
• Negative pregnancy test and willingness to use contraceptive measures during study treatment for women with childbearing potential (i.e \<. 2 years post-menopausal)

You may not qualify if:

• Investigators, site personnel directly affiliated with this study, and their immediate families
• Acute risk for suicide (MADRS, item 10 score of ≥4 or suicidal attempt in the present episode
• Treatment with electroconvulsive therapy in the present episode.
• Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants).
• Any other relevant psychiatric axis-I- and/or axis-II-disorder.
• Any relevant instable medical condition.
• Individuals diagnosed with a significant neurological disorder or insult including, but not limited to:
• Increased intracranial pressure
• Space occupying brain lesion
• History of cerebrovascular accident
• Transient ischemic attack within two years
• Cerebral aneurysm, dementia
• Parkinson's disease
• Huntington's chorea
• Multiple sclerosis

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich

Munich, 80336, Germany

RECRUITING

Related Publications (2)

• Kumpf U, Ezim H, Stadler M, Burkhardt G, Palm U, Dechantsreiter E, Padberg F. Transcranial direct current stimulation as treatment for major depression in a home treatment setting (HomeDC trial): study protocol and methodology of a double-blind, placebo-controlled pilot study. Pilot Feasibility Stud. 2023 Dec 15;9(1):197. doi: 10.1186/s40814-023-01423-x.

  PMID: 38102647 DERIVED

• Kumpf U, Palm U, Eder J, Ezim H, Stadler M, Burkhardt G, Dechantsreiter E, Padberg F. TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study. Eur Arch Psychiatry Clin Neurosci. 2023 Oct;273(7):1403-1420. doi: 10.1007/s00406-023-01620-y. Epub 2023 May 16.

  PMID: 37191697 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Ulrike Kumpf, MD

CONTACT

004917661535471; ulrike.kumpf@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Group Leader Neuromodulation And Multimodal NeuroImaging

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: December 29, 2021
• Study Start: February 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: April 1, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)