ChildrenEarly Phase 1NCT06267339
Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents
A Early Phase 1 study testing transcranial random noise stimulation in people with Children, run by Burke Medical Research Institute at 1 site in United States.
Trial summary
The goal of this study is to compare motor learning rates on two different tasks, when combined with non-invasive brain stimulation. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Children
- What is being tested?
- transcranial random noise stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 10-17 years
- Ability to follow two-step instructions
- Provides informed consent
Who cannot join
- Presence of illness, disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Neurological Institute
White Plains, New York, 10605
About this study
The goal of this study is to compare motor learning rates on two different tasks, when combined with non-invasive brain stimulation.
Read the 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.
- Conditions
- Children
- Being tested
- transcranial random noise stimulation, Sham stimulation
- Keywords
- typically developing children, motor learning, controls, grasp, reach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial random noise stimulationDevice
This intervention will give children tRNS during reaching or grasping repetitive movements.
Sham stimulationDevice
This intervention will give children sham stimulation during reaching or grasping repetitive movements.
| Study group | Role | What they receive |
|---|---|---|
| Grasp Task | Experimental | Participants will practice a fine motor grasping task for 20 min during tRNS or sham stimulation. Receives: 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. Receives: Device: transcranial random noise stimulation; Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Grasp score
Participants will be asked to perform a grasping task, scored by number of pegs placed in a board.
Measured: 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.
Measured: Immediately before vs. Immediately after brain stimulation
Secondary outcomes (2)
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.
Measured: 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.
Measured: Immediately before vs. Immediately after brain stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Friel, PhD, Principal investigator, Burke Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267339
- Sponsor's protocol ID
- TD_tRNS
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will upload de-identified data onto our website and the NIH data sharing website (DASH).
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents
- ClinicalTrials.gov ID
- NCT06267339
- Acronym / sponsor ID
- TD_tRNS
- Conditions
- Children
- Keywords
- typically developing children, motor learning, controls, grasp, reach
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grasp Task | Experimental | Device: transcranial random noise stimulation, Device: Sham stimulationParticipants will practice a fine motor grasping task for 20 min during tRNS or sham stimulation. |
| Reach Task | Experimental | Device: transcranial random noise stimulation, Device: Sham stimulationParticipants will practice a reaching task for 20 min during tRNS or sham stimulation. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 10-17 years
- Ability to follow two-step instructions
- Provides informed consent
Key exclusion criteria (1 listed)
- Presence of illness, disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial random noise stimulationThis intervention will give children tRNS during reaching or grasping repetitive movements. | Device | Grasp Task, Reach Task |
| Sham stimulationThis intervention will give children sham stimulation during reaching or grasping repetitive movements. | Device | Grasp Task, Reach Task |
Primary outcome
Change in Grasp score
Time frame: 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.
Change in Reach score
Time frame: 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.
2 secondary outcomes
Change in Graded Redefined Assessment of Strength, Prehension assessment (GRASSP)
Time frame: Immediately before vs. Immediately after brain stimulation
Change in score on second reaching task
Time frame: Immediately before vs. Immediately after brain stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Yes. We will upload de-identified data onto our website and the NIH data sharing website (DASH).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Friel, PhD principal investigator
Burke Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing transcranial random noise stimulation in people with Children, run by Burke Medical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Friel, PhD (19143683116, kaf3001@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Grasp score (time frame: Immediately before vs. Immediately after brain stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.