Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents

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

Study Overview

• Status: Not yet recruiting
• Conditions: Children
• Intervention / Treatment: Device: transcranial random noise stimulation; Device: Sham stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kathleen Friel, PhD; Phone Number: 19143683116; Email: kaf3001@med.cornell.edu
• Study Contact Backup: Name: Shivakeshavan Ratnadurai-Giriharan, PhD; Phone Number: 191436383160; Email: shr3006@med.cornell.edu

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Burke Neurological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 10-17 years
• Ability to follow two-step instructions
• Provides informed consent

Exclusion Criteria:

• Presence of illness, disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grasp Task; Participants will practice a fine motor grasping task for 20 min during tRNS or sham stimulation.	Device: transcranial random noise stimulation; This intervention will give children tRNS during reaching or grasping repetitive movements.; Device: Sham stimulation; This intervention will give children sham stimulation during reaching or grasping repetitive movements.
Experimental: Reach Task; Participants will practice a reaching task for 20 min during tRNS or sham stimulation.	Device: transcranial random noise stimulation; This intervention will give children tRNS during reaching or grasping repetitive movements.; Device: Sham stimulation; This intervention will give children sham stimulation during reaching or grasping repetitive movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Burke Medical Research Institute
• Investigators: Principal Investigator: Kathleen Friel, PhD, Burke Neurological Institute

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: motor learning; controls; typically developing children; grasp; reach
• Other Study ID Numbers: TD_tRNS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will upload de-identified data onto our website and the NIH data sharing website (DASH).
• IPD Sharing Time Frame: Data will be uploaded within 2 months of study completion and will be available in perpetuity.
• IPD Sharing Access Criteria: Potential users will need to join DASH to access our data. Anyone who completes the DASH registration will be able to access our data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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