Home-based Transcranial Direct Current Stimulation in Postpartum Depression: the Feasibility Study and Pilot Study

NCT05046405 | Not Yet Recruiting FDA Device

• 2 other identifiers: 2020.02059.CEECINDPTDC/PSI-GER/3110/2021
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postnatal Depression

Keywords

Depression; Postnatal; Postnatal Depression; Transcranial Direct Current Stimulation; Feasibility study; Pilot Study

Outcome Measures

Primary Outcomes (5)

• Feasibility of the intervention - Number of completed tDCS applications

  Study reports on the number of completed tDCS applications

  At end of treatment (cycle 1 or 2; each cycle is 3 weeks)

• Change from Baseline on the feasibility of the intervention according to patients.

  The Acceptability Scale for tDCS treatments - patients version (ACCEPT-tDCS) is a 15-item self-report questionnaire on acceptability of tDCS by patients with a minimum score of 15 and a maximum score of 60. Higher scores correspond to increased acceptability.

  At baseline, at end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.

• Change across treatment and follow-up time points on the feasibility of the intervention - Compliance with symptom monitoring

  Study reports on patients compliance with symptom monitoring

  Weekly from week 1 to week 3 (or week 6 if 2 cycles; each cycle is 3 weeks) and at 1 month follow-up

• Change across treatment and follow-up time points on the feasibility of the assessment procedures - Compliance with outcomes assessment visits

  Study Reports on patients compliance with outcomes assessment visits.

  At the end of treatment cycle 1 and the end of treatment cycle 2 (if 2 cycles are prescribed; each cycle is 3 weeks), and at 1 month follow-up

• Change from baseline depressive symptoms.

  Change across treatment and follow-up time points on the Edinburgh Postpartum Depression Scale (EPDS), a 10-item questionnaire to assess the presence and severity of clinically relevant depressive symptoms in the prior week using a 4-point scale. Self-report questionnaire to assess depressive symptoms in the postpartum (through e-health). Scores range between 10 and 40 and higher scores correspond to increased presence/severity of depressive symptoms.

  At baseline and weekly, from week 1 to week 3 (or from week 1 to week 6 if 2 cycles were prescribed) and 1 month follow-up

Secondary Outcomes (23)

• Change from Baseline on the feasibility of the intervention according to Health Providers

  At baseline, at end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.

• Feasibility of the intervention - tDCS Adverse Effects

  Daily during intervention (3 weeks or 6 weeks when adequate) and 1 month follow-up

• Feasibility of the intervention -Health Technology Users' Satisfaction Survey

  At the end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.

• Change from Baseline on the feasibility of the assessment procedures - Acceptability of outcomes assessment visits by women

  At baseline, at the end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.

• Change from Baseline on the feasibility of the assessment procedures - Acceptability of outcomes assessment visits (newborn-infants)

  At baseline, at the end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.

Study Arms (1)

home-based remotely supervised tDCS

EXPERIMENTAL

The intervention combines home-based tDCS (1 or 2 cycles of 15 daily sessions for 3 weeks/cycle at 2 mA for 30 minutes) with tele-health for remote supervision and e-health for self-monitoring of depressive symptoms.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

home-based remotely supervised tDCS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Medication-free women with moderate to severe MD episode according to the Montgomery Asberg Depression Rating Scale (MADRS\>7), and peripartum onset, diagnosed before delivery or between the second week and month 6 postpartum
• Between 18-45 years of age
• Pregnancy to term
• Uncomplicated delivery to a healthy newborn
• Must be able to manage the technical aspects of the intervention.

You may not qualify if:

• tDCS contraindications
• Previous experience with tDCS
• Mental health disorder other than unipolar depression or anxiety
• Suicidal ideation.

Sponsors & Collaborators

• Ana Ganho Ávila: lead
• Unidade Local de Saúde de Coimbra, EPE: collaborator

Related Publications (30)

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MeSH Terms

Conditions

Depression, Postpartum; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ana Ganho-Ávila, PhD

  University of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Ganho-Ávila, PhD

CONTACT

00351968106007; ganhoavila@fpce.uc.pt

Mariana Moura Ramos, PhD

CONTACT

00351 918579020; marianamramos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Model Details: Feasibility studies aim to inform large RCT studies. Thus, for the feasibility study, the investigators aim to inform the practicality of the future Phase-III RCT and to unveil threats to the validity of the efficacy outcomes. Within a users'-centred approach and co-designed methodology, the investigators will assess safety, feasibility of the intervention, and feasibility of procedures for outcomes' assessment. Additionally, the investigators will estimate recruitment/retention and sample size. A consequent underpowered pilot study will be conducted following the achieved static protocol, based on the assumption that the procedures are well defined, serving the purpose of gathering preliminary information and testing the study protocol. Both the feasibility and the pilot studies will be open-label, single arm, single-site longitudinal studies.

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: September 16, 2021
• Study Start: October 2, 2022
• Primary Completion: January 31, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share