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Remotely Non-invasive Brain Stimulation and Videogame to Alleviate Depression

Primary Purpose

Major Depressive Disorder

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

active tDCS

sham tDCS

cognitive and emotional control video game

sham video game

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring cognitive control, non-invasive brain stimulation, transcranial direct current stimulation, VideoGame, self-application, home-based, feasibility, efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Men and woman 18-65 years of age.
Primary Diagnostic and Statistical Manual (DSM-5) diagnosis of Major Depressive Disorder (MDD), with a single or recurrent episode with the additional requirement of a current episode with a duration of ≥4 weeks.
Current depressive episode lasts less than 5 years (the current and previous depressive episodes are demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-5 definition of MDD).
Total Hamilton-21 score ≥ 13 at screening visit.
Capable and willing to provide informed consent. Patients without antidepressant medication or patients on an adequate (i.e., at least lowest effective) and stable (i.e., for ≥ 6 weeks) dosage of SSRI (Escitalopram, Citalopram, Sertralin, Paroxetin, Fluvoxamin, Fluoxetin), SSNRI (Duloxetin, Venlafaxin) or Others (Mirtazapin, Agomelatin, Vortioxetine)
Concomitant psychotherapy is allowed if ongoing for at least 3 months prior to baseline.

Exclusion Criteria:

Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
Addiction to gaming as assessed by the Gaming Disorder Test (GDT).
Individuals diagnosed with the following psychiatric conditions (current unless otherwise stated):
- Depression assessed as secondary to a general medical condition or substance-induced
- Substance abuse or substance dependence (except nicotine, caffeine) in the last 6 months
- Psychotic disorder (lifetime)
- Bipolar disorder (I and II; lifetime)
- Eating disorder if stated as primary diagnosis
- Obsessive compulsive disorder if stated as primary diagnosis
- Post-traumatic stress disorder if stated as primary diagnosis
- Generalized anxiety disorder if stated as primary diagnosis
- Panic disorder/ social anxiety if stated as primary diagnosis
- Personality disorder if stated as primary diagnosis
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
Electroconvulsive therapy (ECT) treatment in current episode
History of tDCS, except for single tDCS sessions in experimental studies
Use of any investigational drug within 6 weeks from baseline
Suicidal risk based on MADRS item 10 score of 4-6 or attempted suicide in current episode
Acute, unstable cardiac disease
Intracranial implant or any other metal object within or near the head (excluding the mouth) that cannot be safely removed; implanted neuro-stimulators
Known or suspected pregnancy (according to pregnancy test), and women of childbearing potential not using effective contraception
History of seizures
Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants)
Any relevant unstable medical condition (e.g. acute, unstable cardiac disease)

Sites / Locations

Ludwig-Maximilian University
Hadassah University Hospital
Riga Stradins University (RSU)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active treatment

Sham treatment

Arm Description

active tDCS (using the Neuroelectrics Starstim tCS 5G kit) and cognitive and emotional control video game

sham tDCS (using the Neuroelectrics Starstim tCS 5G kit) and non-active videogame

Outcomes

Primary Outcome Measures

Feasibility of treatment

Feasibility is met if a patient will complete 20 sessions per protocol with a probability of more than 50.00%.Completion per protocol is achieved, if the patient completes 20 sessions per protocol with a probability of more than 50 percent.

Secondary Outcome Measures

Efficacy-Improvement on the MADRS scores compared to baseline.

Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline. The MADRS scores severity of depression on a scale from 0-60. Higher scores indicate worse depression. A total score between 0-6 indicates that the patient is in the normal range (no depression), 7-19 indicates mild depression, 20-34 indicates moderate depression, and a score of 35 and greater indicates severe depression.

Full Information

NCT ID

NCT04953208

First Posted

June 7, 2021

Last Updated

September 20, 2023

Sponsor

Mor Nahum

Collaborators

Hadassah Medical Organization, Ludwig-Maximilians - University of Munich, Riga Stradins University

1. Study Identification

Unique Protocol Identification Number

NCT04953208

Brief Title

Remotely Non-invasive Brain Stimulation and Videogame to Alleviate Depression

Official Title

The DiSCoVeR Project: Examining the Synergistic Effects of a Cognitive Control Videogame and a Self-administered Non-invasive Brain Stimulation on Alleviating Depression

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 22, 2021 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mor Nahum

Collaborators

Hadassah Medical Organization, Ludwig-Maximilians - University of Munich, Riga Stradins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Treatment is often challenging; up to 40% of patients do not benefit sufficiently from existing antidepressant interventions including trials of medication and psychotherapy. Up to 25% of patients manifest a chronic course of illness, resulting in a need for additional treatment options. The DiSCoVeR trial is a multi-site, double-blind, sham-controlled, proof-of concept randomized controlled trial (RCT). The study aims to investigate the feasibility and efficacy of an innovative, combined treatment approach, incorporating transcranial direct current stimulation (tDCS) along with a custom-made video game designed to enhance cognitive control in patients with major depressive disorder (MDD). Patients diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS along with an active videogame or sham tDCS + sham game for 6 weeks. Follow-up per patient is 6 weeks following treatment. Before, during and after the treatment period different assessment scales will be conducted to record neuropsychological features and the course of symptom changes.

Detailed Description

Major Depressive Disorder (MDD) is a prevalent, seriously impairing, and often recurrent mental disorder. It has been ranked as a leading cause of disability worldwide by the World Health Organization (WHO) as measured by years lived with disability. A considerable number of patients with MDD experience a chronic course of illness and approximately one third of MDD patients do not respond sufficiently to pharmacological treatment, calling for treatment alternatives. Non-invasive brain stimulation techniques (NIBS) such as tDCS targeting prefrontal cortical areas have emerged as a safe, promising, and cost-effective alternative to traditional treatment options in patients with MDD. This study focuses not only on an overall reduction of depressive symptoms, but also an alleviation of cognitive control deficits in particular, since patients with MDD often suffer from cognitive control deficits. tDCS has been shown to directly modulate cognitive control functions in healthy participants and in depressed patients. Another approach to directly modulate cognitive control functions is cognitive control training. In the present study, an engaging and captivating cognitive control training designed as an action video game will be employed. The primary objective is to test the feasibility and efficacy of this innovative, combined treatment approach for self application, concurrently applying both interventions (tDCS + cognitive control training) in patients suffering from MDD. Additionally, participants have the opportunity to choose to take part in two adjunctive assessments: a biological assessment which includes salivary samples and a multimodal imaging paradigm (fMRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

cognitive control, non-invasive brain stimulation, transcranial direct current stimulation, VideoGame, self-application, home-based, feasibility, efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active treatment

Arm Type

Active Comparator

Arm Description

active tDCS (using the Neuroelectrics Starstim tCS 5G kit) and cognitive and emotional control video game

Arm Title

Sham treatment

Arm Type

Sham Comparator

Arm Description

sham tDCS (using the Neuroelectrics Starstim tCS 5G kit) and non-active videogame

Intervention Type

Device

Intervention Name(s)

active tDCS

Intervention Description

Treatment will be applied daily 5 days/week for a period of 6 weeks, which equals a tDCS stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

Intervention Type

Device

Intervention Name(s)

sham tDCS

Intervention Description

sham stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

Intervention Type

Behavioral

Intervention Name(s)

cognitive and emotional control video game

Intervention Description

a video game targeting cognitive and emotional control. total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

Intervention Type

Behavioral

Intervention Name(s)

sham video game

Intervention Description

a video game which does not target cognitive control, played for total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

Primary Outcome Measure Information:

Title

Feasibility of treatment

Description

Time Frame

Six weeks

Secondary Outcome Measure Information:

Title

Efficacy-Improvement on the MADRS scores compared to baseline.

Description

Time Frame

six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Men and woman 18-65 years of age. Primary Diagnostic and Statistical Manual (DSM-5) diagnosis of Major Depressive Disorder (MDD), with a single or recurrent episode with the additional requirement of a current episode with a duration of ≥4 weeks. Current depressive episode lasts less than 5 years (the current and previous depressive episodes are demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-5 definition of MDD). Total Hamilton-21 score ≥ 13 at screening visit. Capable and willing to provide informed consent. Patients without antidepressant medication or patients on an adequate (i.e., at least lowest effective) and stable (i.e., for ≥ 6 weeks) dosage of SSRI (Escitalopram, Citalopram, Sertralin, Paroxetin, Fluvoxamin, Fluoxetin), SSNRI (Duloxetin, Venlafaxin) or Others (Mirtazapin, Agomelatin, Vortioxetine) Concomitant psychotherapy is allowed if ongoing for at least 3 months prior to baseline. Exclusion Criteria: Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption). Addiction to gaming as assessed by the Gaming Disorder Test (GDT). Individuals diagnosed with the following psychiatric conditions (current unless otherwise stated): Depression assessed as secondary to a general medical condition or substance-induced Substance abuse or substance dependence (except nicotine, caffeine) in the last 6 months Psychotic disorder (lifetime) Bipolar disorder (I and II; lifetime) Eating disorder if stated as primary diagnosis Obsessive compulsive disorder if stated as primary diagnosis Post-traumatic stress disorder if stated as primary diagnosis Generalized anxiety disorder if stated as primary diagnosis Panic disorder/ social anxiety if stated as primary diagnosis Personality disorder if stated as primary diagnosis 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 Electroconvulsive therapy (ECT) treatment in current episode History of tDCS, except for single tDCS sessions in experimental studies Use of any investigational drug within 6 weeks from baseline Suicidal risk based on MADRS item 10 score of 4-6 or attempted suicide in current episode Acute, unstable cardiac disease Intracranial implant or any other metal object within or near the head (excluding the mouth) that cannot be safely removed; implanted neuro-stimulators Known or suspected pregnancy (according to pregnancy test), and women of childbearing potential not using effective contraception History of seizures Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants) Any relevant unstable medical condition (e.g. acute, unstable cardiac disease)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mor Nahum, PhD

Phone

0547326655

mor.nahum@mail.huji.ac.il

First Name & Middle Initial & Last Name or Official Title & Degree

Omer Bonne, Professor Medical Doctor

bonne@hadassah.org.il

Facility Information:

Facility Name

Ludwig-Maximilian University

City

Munich

ZIP/Postal Code

80336

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Esther Dechantsreiter

Esther.Dechantsreiter@med.uni-muenchen.de

First Name & Middle Initial & Last Name & Degree

Frank Padberg, M.D.

Facility Name

Hadassah University Hospital

City

Jerusalem

ZIP/Postal Code

12000

Country

Israel

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alon Morash

alonmorash@gmail.com

First Name & Middle Initial & Last Name & Degree

Omer Bonne, M.D.

Facility Name

Riga Stradins University (RSU)

City

Riga

Country

Latvia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Rubene, M.D.

lindarubene93@gmail.com

First Name & Middle Initial & Last Name & Degree

Elmars Rancans, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33798562

Citation

Padberg F, Bulubas L, Mizutani-Tiebel Y, Burkhardt G, Kranz GS, Koutsouleris N, Kambeitz J, Hasan A, Takahashi S, Keeser D, Goerigk S, Brunoni AR. The intervention, the patient and the illness - Personalizing non-invasive brain stimulation in psychiatry. Exp Neurol. 2021 Jul;341:113713. doi: 10.1016/j.expneurol.2021.113713. Epub 2021 Mar 31.

Results Reference

result

PubMed Identifier

16554525

Citation

Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006 Mar 23;354(12):1231-42. doi: 10.1056/NEJMoa052963.

Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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Citation

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Citation

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Results Reference

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Citation

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Results Reference

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Citation

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Citation

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Results Reference

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PubMed Identifier

36271928

Citation

Dechantsreiter E, Padberg F, Morash A, Kumpf U, Nguyen A, Menestrina Z, Windel F, Burkhardt G, Goerigk S, Morishita T, Soldini A, Ahissar S, Cohen T, Pasqualotto A, Rubene L, Konosonoka L, Keeser D, Zill P, Assi R, Gardier R, Vinals R, Thiran JP, Segman R, Benjamini Y, Bonne O, Hummel FC, Bavelier D, Rancans E, Nahum M. Examining the synergistic effects of a cognitive control video game and a home-based, self-administered non-invasive brain stimulation on alleviating depression: the DiSCoVeR trial protocol. Eur Arch Psychiatry Clin Neurosci. 2023 Feb;273(1):85-98. doi: 10.1007/s00406-022-01464-y. Epub 2022 Oct 22.

Results Reference

derived

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Remotely Non-invasive Brain Stimulation and Videogame to Alleviate Depression

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