Use of brain stimulation for treatment of Depression

Recruiting

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

Registration Number: CTRI/2023/03/050546

Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary: Major depressive disorder (MDD) is a deliberating mentaldisorder with a high prevalence, and it produces heavy burden and suicide. Itis one of the most common psychiatric disorders, but pharmacologicaltreatments are ineffective in a substantial fraction of patients and areaccompanied by unwanted and very serious side effects. Therefore, inaddition to antidepressants treating MDD, non-pharmacological interventionshave been proposed to treat MDD.

Personalized interventions for people suffering from psychiatricconditions at all stages of illness have seen an evolution in the past fewyears, from genomic-based subtyping and imaging-based subtyping for theoptimization of first-line treatment selection to new methods forindividualized image-guided targeting in patients via invasive brainstimulation or non-invasive brain stimulation. Recent literature providesexciting new proof-of-concept strategies for the correction of patient-specificdysfunctions in emotionalâ€“cognitive brain circuits for depression bynon-invasive neuromodulation strategies like transcranial direct currentstimulation (tDCS). Transcranial Direct Current stimulation (tDCS) has beenshown to be an effective treatment for depression that can be made portable andused safely, in the privacy of people homes. It could act as the first line ofdefense treatment for depression. In this study, we seek further validation onthe efficacy of tDCS for depression.

This proof-of-concept study intends to recruit 20individuals suffering from MDD fulfilling the inclusion and exclusion criterionrandomly dividing them to receive either active or sham tDCS. 10 patients wouldbe recruited for active tDCS arm and 10 will be included in sham tDCS arm.The outcome parameters would be standard questionnaire-based evaluation methodfor depression - Montgomery and Asberg Depression Rating Scale(MADRS), Hamilton Depression Rating Scale (HDRS-17) and Clinical GlobalImpressions (CGI) scale. In addition, electroencephalography (EEG) andfunctional near infra-red spectroscopy (fNIRS) and Magnetic resonance imaging(MRI) based markers will also be evaluated to analyze if there could be anyputative quantitative biomarker for treatment related progress indepression. Depression questionnaires and cognitive batteries will beperformed before the 1st session, after the 10th session and after the 20thsession of tDCS as well as 4 weeks after the last tDCS session. Sessions willbe conducted twice daily over 10 working days. Stimulation will begin for20 min in a single session, two sessions in a day separated by an inter-sessioninterval of at least 3 hours. Participants in active group will receive stimulationduring the entire 20 min session while those in sham group will receivestimulation only during the ramp up and ramp down period of about 30 sec sothat the participant remain blind to the stimulation delivery. The brainimaging (fNIRS, qEEG & MRI) will be done at baseline before beginning thefirst tDCS session, repeated after completion of last tDCS session and after 24weeks (about 6 months) of last tDCS session. Pre- and post-stimulation sessionEEG will be recorded at resting state daily, and for select event relatedpotential (ERP) before the 1st session, and after the 20th session oftDCS. Analysis will be done using SPSS with p value significant at 0.05.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 20

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.Ability to read Hindi or English language 6.Willing to give informed consent 7.Medication naÃ¯ve or Treatment free from prior 2 weeks or on a stable standard antidepressant regimen {including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic (TCAs)} with no change in treatment 4-weeks prior to tDCS intervention 8.HAMD score â‰¥ 24 (severe depression)(Chistyakov et al., 2010; Goodman et al., 2006).

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.Implanted metal in their body 13.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).	At baseline before beginning tDCS session and then after 10 and 20 sessions as well as after 4 weeks of last tDCS session

Secondary Outcome Measures

Name	Time	Method
Change in parameters obtained in EEG, fNIRS and MRI for correlation to symptom improvement	At baseline before beginning tDCS session and then after 20 sessions and after 24 weeks of last tDCS session

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