- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07156318
- Original Trial
Drumming Lessons' Influence on Children With Down Syndrome
May 15, 2026 updated by: Amy Needham, Vanderbilt University
Effects of Drumming Lessons on Brain and Behavior in Children With Down Syndrome
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Down syndrome (DS) is the most common chromosomal cause of cognitive disability, and it affects approximately 1 in 700 live births.
Although the genetic etiology of DS (a complete or partial third 21st chromosome) has been known for over 50 years, many fundamental questions about how to support high quality of life for individuals with DS remain unanswered.
One area of relative weakness in DS is Inhibitory Control (IC).
This skill is important for daily tasks such as following directions, making decisions, and managing money among other tasks.
Existing research demonstrates a clear link between playing the drums and IC.
In the proposed research, we will conduct an experiment in which 7- to 12-year-old children are randomly assigned to the Experimental (EXP) and Wait List Control (WLC) conditions.
In the EXP condition, children will receive drumming lessons between Visit 1 and Visit 2, and in the Wait List Control group, children will receive drumming lessons after Visit 2. In this way, all children will receive drumming lessons, but only the EXP group will show effects of the drumming lessons in Visit 2. Testing conducted during Visits 1 and 2 will include behavioral and neural measures of inhibitory control and drumming, neural measures of beat perception, and parent report of social behavior (via Standardized questionnaire).
Our predictions are that children in the EXP condition will show improvements in both measures of IC and increases in precision in the beat perception and drumming tasks.
We also expect that parent report of children's behavior on the social skills questionnaire will show improvement.
Across the EXP and WLC conditions, we expect no differences at Visit 1 but significant differences between conditions at Visit 2.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amy Needham, PhD
- Phone Number: 16154999992
- Email: amy.needham@vanderbilt.edu
Study Contact Backup
- Name: Caroline Danforth, MS
- Phone Number: (615) 343-1079
- Email: caroline.danforth@vanderbilt.edu
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Vanderbilt University
-
Contact:
- Caroline Danforth, MS
- Phone Number: 615-343-1079
- Email: vuhandsonplaylab@gmail.com
-
Contact:
- Alison Rubin, BA
- Phone Number: 615-343-1079
- Email: vuhandsonplaylab@gmail.com
-
Principal Investigator:
- Amy Needham, PhD
-
Sub-Investigator:
- Miriam Lense, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Down syndrome
Exclusion Criteria:
- Already taken drumming lessons
- Uncorrected hearing loss
- Uncorrected vision loss
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
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.
|
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.
|
|
Other: Control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Zoo task
Time Frame: Baseline to two months
|
Behavioral "Go/No go" task done on a computer designed to assess children's inhibitory control
|
Baseline to two months
|
|
Statue task
Time Frame: Baseline to two months
|
Child is encouraged to 'become a statue' by holding their body in a position and not moving
|
Baseline to two months
|
|
Beat Perception
Time Frame: Baseline to two months
|
EEG measure of brain activity during passive listening to music
|
Baseline to two months
|
|
Beat production
Time Frame: Baseline to two months
|
EEG and behavioral measures of when child thinks beat is happening during music or metronome
|
Baseline to two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy Needham, PhD, Vanderbilt University
- Study Director: Miriam Lense, PhD, Vanderbilt University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
August 15, 2025
First Submitted That Met QC Criteria
September 3, 2025
First Posted (Actual)
September 5, 2025
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 230465
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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