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Home-based Transcranial Direct Current Stimulation in Postpartum Depression: the Feasibility Study and Pilot Study
Sponsor: Ana Ganho Ávila
Summary
Postpartum Depression (PPD) is a Major Depressive (MD) Disorder occurring within the 12 months after delivery with negative effects to the mother, the child and the family and an estimated prevalence in Europe of 10-15%. Non-invasive Transcranial Direct Current Stimulation (tDCS) has been suggested to PPD, as it combines antidepressant effects with low risks, being equivalent to pharmacotherapy, and showing faster response than psychotherapy. tDCS uses a weak electric current applied to the scalp, modulating neurons' firing rate and neuroplasticity of cerebral circuits to counteract dysfunctional connectivity and inter-hemispheric imbalance in MD. tDCS portability led to its introduction as a home-based intervention and trials assessing home-based tDCS in MD were successful, proved its feasibility and showed good acceptance and benign effect in patients' self-efficacy. Hence, combining home-based tDCS with eHealth systems to support data collection and teleHealth for remote health care has shown positive results in other neuropsychiatric disorders. To uptake tDCS to PPD, further research is needed. To pursue the needed regulatory steps, current consensus on the primary hypothesis of efficacy is that future phase-III studies must be supported by the identification of biotypes of depression and should include cost-effectiveness analysis to model its economic advantage and inform Health Technology Analysis. 4MUMs, within an iterative user-centred and co-design approach will adopt a combined intervention (home-based tDCS + eHealth system + teleHealth system) for PPD, conduct a dynamic feasibility study of the data collection procedures and intervention, and test these in a single-arm pilot study towards the first large-sample multicentre Phase-III RCT protocol aimed at testing home-based tDCS efficacy in PPD.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-10-02
Completion Date
2026-09-30
Last Updated
2021-09-16
Healthy Volunteers
No
Conditions
Interventions
Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) has been suggested to the peripartum period combining antidepressant effects with low risks. In tDCS a low intensity constant current is delivered to the scalp with sub-threshold effect on neurons' resting membrane potential. Long stimulation sessions lead to lasting effects and neuroplastic changes. Local tDCS effects target calcium-dependent synaptic plasticity and distal effects alter the networks' connectivity, synchronicity and oscillatory patterns. tDCS applications aim to counteract the hypoactivity of the frontoparietal network and the left sided hyperactivity of the default mode network associated with depressive symptoms.