on-invasive brain stimulation for Depressio
- Conditions
- Health Condition 1: G- Mental Health
- Registration Number
- CTRI/2018/09/015772
- Lead Sponsor
- Director NIMHANS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
1.Patients aged < 18 and > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Clinical scores: HDRS, MADRS, CGI, <br/ ><br>2.HRV measures: both time and frequency domain measures of heart rate variability <br/ ><br>3.Cortical excitability and plasticity measures <br/ ><br>4. Metaplasticity effects of tDCS-rTMS on M1 <br/ ><br>Timepoint: Baseline, 15 days and 2 months after the start of neuromodulation therapy
- Secondary Outcome Measures
Name Time Method 1. HRV measures: both time and frequency domain measures of heart rate variability <br/ ><br>2.Cortical excitability and plasticity measures <br/ ><br>3. Metaplasticity effects of tDCS-rTMS on M1 <br/ ><br>Timepoint: Baseline, 15 days and 2 months after the start of neuromodulation therapy