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Non-invasive brain stimulation for Depression

Investigating the efficacy of dual stimulation of tDCS and rTMS Neuro-modulation therapy of Major depression - DNIBS-MD

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015772
Enrollment
140
Registered
2018-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G- Mental Health

Interventions

Intervention1: Dual stimulation of tDCS and rTMS: We plan to study the efficacy of dual stimulation of tDCS and high frequency rTMS at DLPFC as potential and efficacious antidepressant therapies. Gene

Sponsors

Director NIMHANS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Individuals with a diagnosis of moderate or severe depression according to ICD-10 diagnosed by a psychiatrist would be recruited if they continue to have at least moderate depressive symptoms as defined clinically and using the HDRS cut-off score of more than 17 even after at least 4-weeks of adequate antidepressant trial with any conventional antidepressant medication

Exclusion criteria

Exclusion criteria: 1.Patients aged 60 years of age 2.If patient is on any psychotropic (other than antidepressant medications, which is kept constant throughout the study period unless clinically required), anticholinergic or cardiac medications 3.Patients with suicidal tendencies or psychotic depression 4.Patients with any co-morbid cardiac or neurological disorders that can increase the risk of TMS related complications or are having a contraindication for TMS/tDCS treatment 5.Pregnant/lactating patients 6.Failure of other organ systems or systemic illness that could affect autonomic function or participantsâ?? ability to cooperate

Design outcomes

Primary

MeasureTime frame
1.Clinical scores: HDRS, MADRS, CGI, 2.HRV measures: both time and frequency domain measures of heart rate variability 3.Cortical excitability and plasticity measures 4. Metaplasticity effects of tDCS-rTMS on M1 Timepoint: Baseline, 15 days and 2 months after the start of neuromodulation therapy

Secondary

MeasureTime frame
1. HRV measures: both time and frequency domain measures of heart rate variability 2.Cortical excitability and plasticity measures 3. Metaplasticity effects of tDCS-rTMS on M1 Timepoint: Baseline, 15 days and 2 months after the start of neuromodulation therapy

Countries

India

Contacts

Public ContactDr Ann Jubin

NIMHANS

kaviudupa@gmail.com91-9844497111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026