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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06267339
Other study ID # TD_tRNS
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date September 1, 2024
Est. completion date August 31, 2026

Study information

Verified date February 2024
Source Burke Medical Research Institute
Contact Kathleen Friel, PhD
Phone 19143683116
Email kaf3001@med.cornell.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to compare motor learning rates on two different tasks, when combined with non-invasive brain stimulation.


Description:

We will apply transcranial random noise stimulation or sham stimulation. During tRNS, participants will complete a grasping task or a reaching task. Each participant will complete both tasks, with a wait period between each task. Task order will be randomized, such that half the group will begin with each task. We will compare task scored before vs. after tRNS, for each task. This will be a measure of motor learning.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 31, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria: - Age 10-17 years - Ability to follow two-step instructions - Provides informed consent Exclusion Criteria: - Presence of illness, disease

Study Design


Related Conditions & MeSH terms


Intervention

Device:
transcranial random noise stimulation
This intervention will give children tRNS during reaching or grasping repetitive movements.
Sham stimulation
This intervention will give children sham stimulation during reaching or grasping repetitive movements.

Locations

Country Name City State
United States Burke Neurological Institute White Plains New York

Sponsors (1)

Lead Sponsor Collaborator
Burke Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Grasp score Participants will be asked to perform a grasping task, scored by number of pegs placed in a board. Immediately before vs. Immediately after brain stimulation
Primary Change in Reach score Participants will be asked to perform a reaching task to stack cups, scored by time taken to stack all cups. Immediately before vs. Immediately after brain stimulation
Secondary Change in Graded Redefined Assessment of Strength, Prehension assessment (GRASSP) Participants will be asked to perform the GRASSP, scored by tallying points according to the test parametrics. Immediately before vs. Immediately after brain stimulation
Secondary Change in score on second reaching task Participants will be asked to perform a reaching task to stack cups in a different pattern from Primary Outcome #2, scored by time taken to stack all cups. Immediately before vs. Immediately after brain stimulation
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