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tVNS in Children With Prader-Willi Syndrome

Primary Purpose

Prader-Willi Syndrome, Social Behavior

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
tVNS
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prader-Willi Syndrome

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) be between the ages of 8-14 years; (2) have a confirmed diagnosis of PWS by genetic testing; (3) be minimally verbal and able to sit at a table to complete cognitive and behavioral testing; (4) be willing to provide blood samples; and (5) be willing to engage in a 16-week study period (baseline to intervention follow-up).

Exclusion Criteria:

  • (1) currently taking oxytocin and/or arginine vasopressin or related analogs and (2) have a DSM-5 diagnosis of any severe mental or behavioral disorder (e.g. schizophrenia, bipolar disorder, conduct or oppositional defiant disorder) that significantly impacts daily functioning.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    tVNS treatment

    tVNS sham treatment

    Arm Description

    Outcomes

    Primary Outcome Measures

    Social Responsiveness Scale, 2nd Edition (SRS-2)
    Identifies the presence and severity of social impairments in child participants by parent report

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2020
    Last Updated
    May 3, 2021
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04396470
    Brief Title
    tVNS in Children With Prader-Willi Syndrome
    Official Title
    Transcutaneous Vagus Nerve Stimulation in Children With Prader-Willi Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No funding received
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The purpose of the current project is to test the impact of transcutaneous vagus nerve stimulation (tVNS) on social ability in children with Prader-Willi Syndrome (PWS). Social ability and blood neuropeptides associated with social functioning will be measured before and after engagement in 12 weeks of tVNS therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prader-Willi Syndrome, Social Behavior

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tVNS treatment
    Arm Type
    Experimental
    Arm Title
    tVNS sham treatment
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    tVNS
    Intervention Description
    Participants will be randomized to either the tVNS treatment condition or the sham tVNS (placebo) condition. An identical non-invasive tVNS device will be used in both groups. In the active condition, the device is placed on the external earlobe (tragus), which directly stimulates the vagus nerve. In the sham condition, the device is placed on the external earlobe, providing the same sensations as in the treatment condition, but no stimulation to the vagus nerve. Intervention period: Participants will use the device 1-hr per day for 12 weeks per manufacturer's instructions.
    Primary Outcome Measure Information:
    Title
    Social Responsiveness Scale, 2nd Edition (SRS-2)
    Description
    Identifies the presence and severity of social impairments in child participants by parent report
    Time Frame
    pre-post 12 week intervention period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) be between the ages of 8-14 years; (2) have a confirmed diagnosis of PWS by genetic testing; (3) be minimally verbal and able to sit at a table to complete cognitive and behavioral testing; (4) be willing to provide blood samples; and (5) be willing to engage in a 16-week study period (baseline to intervention follow-up). Exclusion Criteria: (1) currently taking oxytocin and/or arginine vasopressin or related analogs and (2) have a DSM-5 diagnosis of any severe mental or behavioral disorder (e.g. schizophrenia, bipolar disorder, conduct or oppositional defiant disorder) that significantly impacts daily functioning.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    tVNS in Children With Prader-Willi Syndrome

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