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NCT05046405: 4MUMs
Home-based Transcranial Direct Current Stimulation in Postpartum Depression: the Feasibility Study and Pilot Study
NA trial testing Transcranial Direct Current Stimulation in Postnatal Depression in 50 participants. Not yet recruiting.
31 January 2024
Quick facts
| Lead sponsor | Ana Ganho Ávila |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 2 October 2022 |
| Primary completion | 31 January 2024 |
| Estimated completion | 30 September 2026 |
Drugs / interventions tested
- Transcranial Direct Current Stimulation
Conditions studied
- Postnatal Depression — all drugs for Postnatal Depression →
Sponsor
Ana Ganho Ávila
Who can join
Adults 18 to 45, female only, with Postnatal Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05046405
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Transcranial Direct Current Stimulation
Trials testing the same drug.
- NCT07496645 — EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE · Phase 3 · not yet recruiting
- NCT07395531 — Effect of Repetitive Bihemispheric Anodal Transcranial Direct Current Stimulation on Motor Function of Patients With Par · Phase 3 · not yet recruiting
- NCT07212634 — Cerebellar Transcranial Direct Current Stimulation for Dysphagia After Supratentorial Stroke · NA · not yet recruiting
- NCT07319143 — The Effect of Transcranial Direct Current Stimulation (tDCS) in Improving Emotion Health · NA · recruiting
- NCT06039605 — Priming Expectations and Motor Learning With tDCS · NA · completed
Other recruiting trials for Postnatal Depression
Currently open trials in the same condition.
- NCT06871397 — Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy · NA · recruiting
- NCT07017621 — Qualitative Study on the Experiences of Mothers 6 to 12 Months After Their Participation in the Mother-baby Groups of th · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05046405 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ana Ganho Ávila
- Last refreshed: 16 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05046405.
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