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

NCT06267339 | Not Yet Recruiting Early Phase 1

• 1 other identifier: TD_tRNS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Children

Keywords

typically developing children; motor learning; controls; grasp; reach

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Graded Redefined Assessment of Strength, Prehension assessment (GRASSP)

  Immediately before vs. Immediately after brain stimulation

• Change in score on second reaching task

  Immediately before vs. Immediately after brain stimulation

Study Arms (2)

Grasp Task

EXPERIMENTAL

Participants will practice a fine motor grasping task for 20 min during tRNS or sham stimulation.

Device: transcranial random noise stimulation; Device: Sham stimulation

Reach Task

EXPERIMENTAL

Participants will practice a reaching task for 20 min during tRNS or sham stimulation.

Device: transcranial random noise stimulation; Device: Sham stimulation

Interventions

transcranial random noise stimulation DEVICE

This intervention will give children tRNS during reaching or grasping repetitive movements.

Grasp Task; Reach Task

Sham stimulation DEVICE

This intervention will give children sham stimulation during reaching or grasping repetitive movements.

Grasp Task; Reach Task

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Presence of illness, disease

Sponsors & Collaborators

• Burke Medical Research Institute: lead

Study Sites (1)

Burke Neurological Institute

White Plains, New York, 10605, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Kathleen Friel, PhD

  Burke Neurological Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Friel, PhD

CONTACT

19143683116; kaf3001@med.cornell.edu

Shivakeshavan Ratnadurai-Giriharan, PhD

CONTACT

191436383160; shr3006@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 20, 2024
• Study Start: September 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be uploaded within 2 months of study completion and will be available in perpetuity.
• 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.

Locations

US (1)