1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [alankritjaiswal@yahoo.co.in].
   


6. For how long will this data be available start date provided 01-05-2023 and end date provided 01-06-2028?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

Treatment Resistant Depression is a common problem clinicians’ worldwide face. There are no widely agreed upon treatment strategies that satisfactorily solve this problem. rTMS has shown promise as an effective tool for treatment resistant depression with significant lowering of scores in depression rating scales over sham rTMS. Its widespread use has been limited by the number of patients who can be treated by existing protocols and concerns about efficacy and clinical relevance f these results. These concerns can be addressed by studying efficacy of HDtDCS primed iTBS in depression where the iTBS protocol will help reduce the time duration spent on therapy of a single patient and priming has shown promising results towards improving the efficacy of neuromodulation. NGF levels have been studied in depressed individuals as well as patients receiving treatment for depression via various modalities (antidepressants, therapy and neuromodulation). The research findings have not provided enough conclusive evidence to establish NGF as a depression biomarker. To the best of our knowledge no study has been conducted so far to see the association of NGF with HDtDCS primed iTBS in treatment resistant depression.

AIM/KEY RESEARCH QUESTIONS

Key questions to be addressed in this study are as follows:

1.                   Whether HDtDCS priming improves the efficacy of iTBS in treatment resistant depression?

2.                   Whether application of HDtDCS primed iTBS in patients with Treatment Resistant Depression causes a change in Nerve Growth Factor levels in the serum?

3.                   Whether NGF levels in active HDtDCS primed group differ significantly from NGF levels in sham HDtDCS primed group?

OBJECTIVES

1.       To compare the efficacy of High-Definition transcranial Direct Current Stimulation primed iTBS in treating Treatment Resistant Depression between active and sham HDtDCS priming.

2.       To measure levels of Nerve Growth Factor in serum of individuals with Treatment Resistant Depression before and after HDtDCS priming in iTBS.

3.       To compare the levels of Nerve Growth Factor levels in the serum of patients receiving Active HDtDCS primed iTBS and Sham HDtDCS primed iTBS.

ALTERNATIVE HYPOTHESIS

1.       Active HDtDCS primed iTBS will be more effective in treating treatment resistant depression than sham HDtDCS primed iTBS.

2.       Nerve Growth Factor levels in the serum in patients with Treatment Resistant Depression after High-Definition Transcranial Direct Current Stimulation primed intermittent Theta Burst Stimulation will be higher than before treatment.

3.       Nerve Growth Factor levels in the serum of patients receiving Active HDtDCS primed iTBS will be higher than Sham HDtDCS primed iTBS.