NCT07156318

Brief Summary

The goal of this clinical trial is to learn if drumming lessons can increase self-control in children with Down syndrome. The main question it aims to answer is whether 2 months of drumming lessons can improve the behavioral control and timing skills in children with Down syndrome. Participants are between 7 and 15 years of age and receive two months of drumming lessons given by a professional drummer with extensive experience working with children with Down syndrome. Children in the experimental group visit our lab once before lessons start and once after lessons are completed. Children in the control group visit our lab twice before they start their lessons. Lab visits include brain recordings taken using a net-style cap, computer tasks, and drumming to music.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

August 15, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

August 15, 2025

Last Update Submit

May 15, 2026

Conditions

Keywords

Children with Down syndrome;Effects of drumming lessonsEffects on brain and behaviorInhibitory controlBeat perceptionIntervention study

Outcome Measures

Primary Outcomes (4)

  • Zoo task

    Behavioral "Go/No go" task done on a computer designed to assess children's inhibitory control

    Baseline to two months

  • Statue task

    Child is encouraged to 'become a statue' by holding their body in a position and not moving

    Baseline to two months

  • Beat Perception

    EEG measure of brain activity during passive listening to music

    Baseline to two months

  • Beat production

    EEG and behavioral measures of when child thinks beat is happening during music or metronome

    Baseline to two months

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group will receive the drumming lesson intervention between baseline and testing approximately 2 to 3 months later, so the effects of the intervention can be assessed in the lab measures.

Behavioral: 2 months of drumming lessons given by a professional drummer with extensive experience working with children with Down syndrome

Control group

OTHER

Children in the Control condition will receive drumming lessons only after they have completed lab baseline and testing measures, about 2 to 3 months later.

Behavioral: Lessons after measurement

Interventions

Receiving lessons after the two lab visits should still offer any possible positive effects to participants while still allowing us to compare the Control group children's behaviors to those of the Experimental group.

Control group

Drumming lessons consisting of how to use hands to drum on djembe drum, using alternating hands to drum, drumming to a metronome and to music.

Experimental group

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Down syndrome

You may not qualify if:

  • Already taken drumming lessons
  • Uncorrected hearing loss
  • Uncorrected vision loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

RECRUITING

Related Publications (1)

  • Cahart MS, Amad A, Draper SB, Lowry RG, Marino L, Carey C, Ginestet CE, Smith MS, Williams SCR. The effect of learning to drum on behavior and brain function in autistic adolescents. Proc Natl Acad Sci U S A. 2022 Jun 7;119(23):e2106244119. doi: 10.1073/pnas.2106244119. Epub 2022 May 31.

    PMID: 35639696BACKGROUND

MeSH Terms

Conditions

Down SyndromeBehavior

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Amy Needham, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR
  • Miriam Lense, PhD

    Vanderbilt University Medical Center

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2025

First Posted

September 5, 2025

Study Start

February 15, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

In this initial investigation, it seems unlikely that data at the participant level would be informative to other researchers. If it becomes clear during the study that sharing of IPD actually would be beneficial, we will recontact participants for their consent to share this information and share those datasets for which we obtain consent.

Locations