Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05172505
Status:
UNKNOWN
Last Update Posted:
2022-10-28
First Post:
2021-10-20
Brief Title:
Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression A Double-blind Placebo-controlled Pilot Trial
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HomeDC
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 parkinsons 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 sessionsweek 30minday 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
There are some studies on the home-treatment approach with tDCS for different mainly neurological disorders such as parkinsons 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 sessionsweek 30minday 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 sessionsweek 30minday 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 MARDS21 vs MARDS21 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 5xweek 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 V1V2V3 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
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 sessionsweek 30minday 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 MARDS21 vs MARDS21 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 5xweek 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 V1V2V3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None