DepressionHomeDCNCT05172505
Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression
A study testing prefrontal tDCS in people with Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- prefrontal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 18Show fewer
- 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
- Epilepsy
- History of seizures
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich
Munich, 80336
Ulrike Kumpf, MD, 49-89-4400-55821, ulrike.kumpf@med.uni-muenchen.de
Frank Padberg, Prof., MD, 49-89-4400-55821, frank.padberg@med.uni-muenchen.de
About this study
Official title: Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression: A Double-blind, Placebo-controlled Pilot Trial
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.
Read more
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.
Read the detailed description
Design:
The study will be conducted in a double-blind, placebo-controlled, parallel-group design with 16 patients per group. Patients with primary diagnosis of MDD according to DSM-5 perform a 6-weeks self-administered treatment with prefrontal tDCS (anode over F3, cathode over 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 stable antidepressant medication or alone. The study will be conducted at the Department of Psychiatry and Psychotherapy of the LMU Munich. Suitable patients will be randomized into two groups after they passed screening. Stratification according to the severity of the depressive symptoms (MARDS<21 vs. MARDS≥21) to distribute patients according to factors influencing the clinical outcome will be also done as well as stratification according to gender. The groups will receive active tDCS or sham-tDCS for a total of 6 weeks (5x/week, 30 min. stimulation). At baseline, an optional baseline cMRI examination with e-field modelling and fMRI will be performed. During the treatment phases, a study visit will take place every 2 weeks. In addition, a study visit will take place after the first week to address any difficulties with self-application at home. After 6 weeks, the primary endpoint will be reached and a final rating will be made after the treatment phase. In the subsequent follow-up phase, a study visit (V5 and V6) will take place 4 weeks and 8 weeks after the last stimulation session. According to the rules of the DepressionDC trial (Padberg et al., 2017) a total of 4 sessions may be missed without a drop out. Missed sessions can be compensated with additional sessions in week 7. This yields a total of 6 study visits with a total protocol duration of 14 weeks. The treatment phase is 6 weeks long with a maximum of 30 tDCS sessions per patient in home treatment.
Patients which continue to have relevant depressive symptoms after the 6 weeks of active or sham tDCS and after completion of the follow up phase will be offered 6 weeks of active treatment after V5. Patients receiving the active phase after V5 will receive an additional 3 study visits with the same scales reported like V1/V2/V3 during this second study phase: V6 after the first 3 weeks of active treatment, V7 after 6 weeks and V8 as a follow up 4 weeks after completion of the second treatment phase. Effects of this second study phase will be analysed in an exploratory way on an intraindividual level.
- Conditions
- Depression
- Being tested
- prefrontal tDCS
- Keywords
- tDCS, Depression, Home Treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prefrontal tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active prefrontal tDCS 2mA 6 weeks 5x/week | Active comparator | Not described Receives: Device: prefrontal tDCS |
| Sham prefrontal tDCS 6 weeks 5x/week | Sham comparator | Not described Receives: Device: prefrontal tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Drop out rates, number of completed stimulation sessions in the treatment phase
Measured: 6 weeks
Secondary outcomes (3)
Safety
side effects and complications encountered, rates of discontinuation of stimulations due to high impedances, number of SAEs and AEs
Measured: 6 weeks
Change in BDI, GAF and CGI
The change in absolute score in the BDI, CGI and GAF after 6 weeks of tDCS treatment and after 4 weeks of follow up compared to the baseline scores
Measured: 10 weeks
Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline
The change in absolute score in the MADRS after 6 weeks of tDCS treatment compared to the baseline MADRS score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Keeser, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172505
- Sponsor's protocol ID
- HomeDC
- Acronym
- HomeDC
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 38102647Kumpf 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.
PubMed 37191697
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression: A Double-blind, Placebo-controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05172505
- Acronym / sponsor ID
- HomeDC / HomeDC
- Conditions
- Depression
- Keywords
- tDCS, Depression, Home Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design:
The study will be conducted in a double-blind, placebo-controlled, parallel-group design with 16 patients per group. Patients with primary diagnosis of MDD according to DSM-5 perform a 6-weeks self-administered treatment with prefrontal tDCS (anode over F3, cathode over 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 stable antidepressant medication or alone. The study will be conducted at the Department of Psychiatry and Psychotherapy of the LMU Munich. Suitable patients will be randomized into two groups after they passed screening. Stratification according to the severity of the depressive symptoms (MARDS<21 vs. MARDS≥21) to distribute patients according to factors influencing the clinical outcome will be also done as well as stratification according to gender. The groups will receive active tDCS or sham-tDCS for a total of 6 weeks (5x/week, 30 min. stimulation). At baseline, an optional baseline cMRI examination with e-field modelling and fMRI will be performed. During the treatment phases, a study visit will take place every 2 weeks. In addition, a study visit will take place after the first week to address any difficulties with self-application at home. After 6 weeks, the primary endpoint will be reached and a final rating will be made after the treatment phase. In the subsequent follow-up phase, a study visit (V5 and V6) will take place 4 weeks and 8 weeks after the last stimulation session. According to the rules of the DepressionDC trial (Padberg et al., 2017) a total of 4 sessions may be missed without a drop out. Missed sessions can be compensated with additional sessions in week 7. This yields a total of 6 study visits with a total protocol duration of 14 weeks. The treatment phase is 6 weeks long with a maximum of 30 tDCS sessions per patient in home treatment.
Patients which continue to have relevant depressive symptoms after the 6 weeks of active or sham tDCS and after completion of the follow up phase will be offered 6 weeks of active treatment after V5. Patients receiving the active phase after V5 will receive an additional 3 study visits with the same scales reported like V1/V2/V3 during this second study phase: V6 after the first 3 weeks of active treatment, V7 after 6 weeks and V8 as a follow up 4 weeks after completion of the second treatment phase. Effects of this second study phase will be analysed in an exploratory way on an intraindividual level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prefrontal tDCS2 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. | Device | Active prefrontal tDCS 2mA 6 weeks 5x/week, Sham prefrontal tDCS 6 weeks 5x/week |
Primary outcome
Feasibility
Time frame: 6 weeks
Drop out rates, number of completed stimulation sessions in the treatment phase
3 secondary outcomes
Safety
Time frame: 6 weeks
Change in BDI, GAF and CGI
Time frame: 10 weeks
Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Derived from this study: PubMed 38102647Kumpf 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.
- Derived from this study: PubMed 37191697Kumpf 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prefrontal tDCS in people with Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrike Kumpf, MD (004917661535471, ulrike.kumpf@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172505, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.