New Mothers Alpha-Stim

NCT04770181 | Withdrawn FDA Device

• 1 other identifier: DCHIRB#00001244
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The birth of a child is a major life event that can be filled with excitement, anticipation and joy. However, the transition and adaptation to new demands, roles, responsibilities, and changes in relationships can be stressful, especially for new mothers. In addition, new mothers typically encounter physiological changes and struggle with concerns about weight gain, body image, sexuality, and other physical difficulties such as fatigue. These problems may generate or exacerbate stress, lead to an actual or perceived crisis and psychological distress. Psychological distress, defined as anxiety, depression, and insomnia, in this study, often increases during the postpartum period and can negatively affect maternal mental health status, maternal and family relationships, and infant-child health. The purpose of this study is to evaluate the effects of cranial electrotherapy stimulation (CES) on anxiety, insomnia, depression, and maternal functioning in first time new mothers following childbirth.

Conditions

Anxiety; Depression; Insomnia; Sleep Quality

Keywords

Cranial Electrotherapy Stimulation (CES); Efficacy; Post Partum; Anxiety; Depression; Insomnia; Sleep Quality; Maternal Functioning

Outcome Measures

Primary Outcomes (1)

• To measure the effect of CES on anxiety in new mothers during the postpartum period.

  The Hamilton Anxiety Rating Scale (HAM-A14)

  Duration is six weeks

Secondary Outcomes (3)

• To measure the effect of CES on depression in new mothers during the postpartum period.

  Duration is six weeks

• To measure the effect of CES on sleep quality in new mothers during the postpartum period.

  Duration is six weeks

• To measure the effect of CES on insomnia in new mothers during the postpartum period.

  Duration is six weeks

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).

Device: Alpha-Stim AID CES (Active Comparator)

Sham Comparator

SHAM COMPARATOR

The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.

Device: Alpha-Stim AID CES (Sham Comparator)

Interventions

Alpha-Stim AID CES (Active Comparator) DEVICE

The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).

Also known as: Alpha-Stim AID

Active Comparator

Alpha-Stim AID CES (Sham Comparator) DEVICE

The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.

Also known as: Alpha-Stim AID

Sham Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is a primiparous new mother, 18-45 years inclusive, who had an uncomplicated vaginal or cesarean birth, gave birth to a healthy baby and both mother and baby are healthy at enrollment and randomization in the study.
• Sexually active female participants of childbearing potential must be self-report practicing, at least, one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception or abstinence. Female participants of childbearing potential must have a negative urine pregnancy test before receiving study treatment.
• Written informed consent must be obtained from the participant before study participation.
• Participant is in good medical health.
• No current abuse of alcohol or other substance.
• Capable of giving informed consent.
• Capable of doing active or sham CES treatments and completing all study requirements independently
• For compliance, participants need to have completed 85% (36) of treatments to continue participation in the study

You may not qualify if:

• Participant had serious complications during or after a vaginal or cesarean delivery.
• Participant had multiple births.
• Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for a mental disorder diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) as determined by medical history and/or self-report.
• Participant is clinically judged by the investigator to be at risk for suicide or is acutely suicidal. Participant has attempted suicide one or more times within the past twelve months.
• Participant has a Hamilton Anxiety Rating Scale (HAM-A14) score above 30 which suggests a very severe clinical level of anxiety symptoms.
• Participant has a Hamilton Depression Rating Scale (HAM-D17) score above 30 which suggests a very severe clinical level of depressive symptoms.
• Participant has a psychiatric condition that would require inpatient or partial psychiatric hospitalization.
• Participant has a significant history of medical disease (i.e. cardiovascular, hepatic (e.g., cirrhosis, hepatitis B or C) renal, gynecological, musculoskeletal, neurological (seizures), gastrointestinal, metabolic, hematological, endocrine, cancer with a metastatic potential or progressive neurological disorders) which could impair reliable participation in the trial or necessitate the use of medication not allowed by this protocol.
• Participant is pregnant, planning to become pregnant. If a participant becomes pregnant, she will be dropped from the study immediately and followed appropriately.
• Participant has had concomitant therapy with another investigational drug, or participation in an investigational drug study within one month before entering this study.
• Participant has a history of poor compliance or in the investigator's judgment any participant who is not compliant with the requirements of the study.
• Participant has had previous trial of CES.

Sponsors & Collaborators

• Christina Murphey, RN, PhD: lead

Study Sites (2)

Primay care; OB-GYN Clinic

Austin, Texas, 78758, United States

Location

Primary care; OB-GYN Clinic

Corpus Christi, Texas, 78412, United States

Location

Related Publications (1)

• Murphey C, Carter P, Price LR, Champion JD, Nichols F. Psychological Distress in Healthy Low-Risk First-Time Mothers during the Postpartum Period: An Exploratory Study. Nurs Res Pract. 2017;2017:8415083. doi: 10.1155/2017/8415083. Epub 2017 Jan 16.

  PMID: 28191350 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Christina Murphey, RN, PhD

  Texas A&M University - Corpus Christi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blocked randomization method will be used to assign participants to active and sham groups. Participants will be assigned to CES treatment or sham CES using a 1:1 ratio. Electromedical Products International, Inc. (EPI) will randomize the assignment of appropriate devices to active or sham groups by using a random list of computer generated numbers (1 for active and 2 for sham) in randomly selected block sizes. The PI and participants are blinded to which participants have Alpha-Stim® CES active or sham devices until data analysis is complete. After the completion of data analysis, blinding will be broken.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: The design for the proposed study is a matched-pair, quasi-experimental, 1:1 randomized, double-blind, sham-controlled clinical trial with a longitudinal component. The analytic technique employed to answer the research questions will be repeated measures analysis of covariance.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)