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

Early Phase 1

Not yet recruiting

• Conditions: Children
• Interventions: Device: transcranial random noise stimulation; Device: Sham stimulation

• Registration Number: NCT06267339
• Lead Sponsor: Burke Medical Research Institute

Brief Summary

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

• Study First Submitted: 2024-01-30
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Study Start: 2024-09-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Presence of illness, disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reach Task	Sham stimulation	Participants will practice a reaching task for 20 min during tRNS or sham stimulation.
Grasp Task	transcranial random noise stimulation	Participants will practice a fine motor grasping task for 20 min during tRNS or sham stimulation.
Grasp Task	Sham stimulation	Participants will practice a fine motor grasping task for 20 min during tRNS or sham stimulation.
Reach Task	transcranial random noise stimulation	Participants will practice a reaching task for 20 min during tRNS or sham stimulation.

Primary Outcome Measures

Name	Time	Method
Change in Reach score	Immediately before vs. Immediately after brain stimulation	Participants will be asked to perform a reaching task to stack cups, scored by time taken to stack all cups.
Change in Grasp score	Immediately before vs. Immediately after brain stimulation	Participants will be asked to perform a grasping task, scored by number of pegs placed in a board.

Secondary Outcome Measures

Name	Time	Method
Change in Graded Redefined Assessment of Strength, Prehension assessment (GRASSP)	Immediately before vs. Immediately after brain stimulation	Participants will be asked to perform the GRASSP, scored by tallying points according to the test parametrics.
Change in score on second reaching task	Immediately before vs. Immediately after brain stimulation	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.

Trial Locations

Locations (1)

Burke Neurological Institute; 🇺🇸 White Plains, New York, United States