Combined use of brain stimulation and cognitive training for treatment of Depression

Not yet recruiting

Conditions: Major depressive disorder, singleepisode, severe without psychotic features,

Registration Number: CTRI/2021/11/037854

Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary: Major depressivedisorder (MDD) is a deliberating mental disorder with a high prevalence, and itproduces heavy burden and suicide. It is one of themost common psychiatric disorders, but pharmacological treatments areineffective in a substantial fraction of patients and are accompanied byunwanted and very serious side effects. Therefore, in addition toantidepressants treating MDD, non-pharmacological interventions have beenproposed to treat MDD.

Personalizedinterventions for people suffering from psychiatric conditions at all stages ofillness have seen an evolution in the past few years, from genomic-basedsubtyping and imaging-based subtyping for the optimization of first-linetreatment selection to new methods for individualized image-guided targeting inpatients via invasive brain stimulation or non-invasive brain stimulation.Recent literature provides exciting new proof-of-concept strategies for thecorrection of patient-specific dysfunctions in emotionalâ€“cognitive braincircuits for depression by non-invasive neuromodulation strategies liketranscranial direct current stimulation (tDCS) with or without combination withcognitive behavior therapy (CBT) or cognitive emotional training (CET). TranscranialDirect Current stimulation (tDCS) has been shown to be an effective treatmentfor depression that can be made portable and used safely, in the privacy ofpeopleâ€™s homes. Combined with digital cognitive behavioural and emotionaltherapies, it could act as the first line of defense treatment for depression. Inthis study, we seek further validation on the efficacy of tDCS for depressionand the efficacy of a combined treatment of tDCS and CET.

This proof-of-conceptstudy intends to recruit 20 individuals suffering from MDD fulfilling theinclusion and exclusion criterion randomly dividing them to receive either tDCSalone or in combination with mobile app based digital CET. 10 patients eachwould be recruited for only tDCS and for the combined treatment of tDCS andCET. The outcome parameters would be standard questionnaire-based evaluationmethod for depression - [Montgomery and Asberg Depression Rating Scale (MADRS)](http://www.veale.co.uk/wp-content/uploads/2010/10/MADRS.pdf), Hamilton Depression Rating Scale(HDRS-17) and Clinical Global Impressions (CGI) scale. In addition,electroencephalography (EEG) based markers will also be evaluated to analyze ifthere could be any putative quantitative biomarker for treatment related progressin depression. Depression questionnairesand cognitive batteries will be performed before the 1st session, after the10th session and after the 20th session of tDCS. Sessions will be conductedtwice daily over 10 working days. Pre- and post-stimulation session EEG will berecorded at resting state daily, and for select event related potential (ERP)before the 1st session, after the 10th session and after the 20th session oftDCS. For each session, pre-session EEG will be recorded at resting state.Stimulation will begin for 20 mins during which the patient will be engaged inone of 5 digital CET tasks. The session will end with another EEG for restingstate. Analysis will be done using SPSS with p value significant at 0.05.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Inclusion criteria 1.Between age 18-55 years 2.Either gender 3.Right-handed individuals 4.Patients fulfilling the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM 5) criteria for the diagnosis of MDD 5.Patients scoring greater than 28 on MADRS 6.The patients who can at least read and write English/Hindi 7.Willing to give informed consent.
8.Drug free (medication naive) or not taking any psychotropic medications except hypnotics from previous two weeks.

Exclusion Criteria

Exclusion criteria 1.Chronic medical or neurological illness (previously diagnosed) 2.Lifetime substance use disorder (excluding tobacco or caffeine) (as per DSM-5) 3.Suffering from or any psychiatric illness other than MDD 4.Not cooperative for testing 5.Past history of significant head injury 6.Known case of intellectual disability 7.Known or suspected pregnancy or currently lactating 8.Head metal implants 9.Subjects with significant suicidal risk upon clinical assessment 10.Any history of seizure 11.Previous history of receiving any brain surgical procedures 12.Electrical or magnetic stimulation on brain in the previous three months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inter-group differences in change in scale scores (HAMD-17, MADRS and CGI).	After 10 and 20 sessions

Secondary Outcome Measures

Name	Time	Method
Change in amplitude of event related potentials obtained in EEG for correlation to symptom improvement	After 20 sessions

Trial Locations

Locations (1): All India Institute of Medical Sciences New Delhi
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences New Delhi
🇮🇳South, DELHI, India
Dr Rohit Verma
Principal investigator
09868005491
rohit.aiims@gmail.com