Accelerating Motor Learning in Pediatrics

NCT03193580 | Completed

• 1 other identifier: REB16-2474
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

Non-invasive brain stimulation can both study and potentially treat neurological disorders. Transcranial direct-current stimulation (tDCS) is an emerging safe and tolerability form of stimulation and has been used increasingly over the last decade. The purpose of this research is to see if two different types of tDCS can improve motor function in healthy children. tDCS has been shown to safely enhance hand motor function in healthy adults, and those that have suffered stroke and other conditions. Recently the investigators demonstrated that tDCS may enhance hand motor function in healthy children, however, how it does so is unknown. In addition to assessing changes in motor function when tDCS is given during motor skill training, the investigators will perform various tests before and after stimulation to understand the changes that happen in the brain accompanying motor skill learning and brain stimulation. The investigators hypothesize that there will be an accelerated acquisition of motor skill, when training is paired with conventional anodal tDCS, HD-tDCS, or sham tDCS.

Conditions

Healthy; Pediatrics

Keywords

Anodal Stimulation Transcranial Direct Current Stimulation; High-Definition Transcranial Direct Current Stimulation; tDCS; Non-invasive brain stimulation; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Change in Left Hand Purdue Pegboard Test Score

  A "baseline" trial will be performed. Each day they will do 15 repetitions for 5 consecutive days. On the fifth day, they will do a post training trial consisting of 3 repetitions.

  Baseline and immediately post-training on day 5

Secondary Outcomes (8)

• Percent change in metabolic markers

  Baseline, post-training on day 5, and 6 weeks following training

• Raw change in functional motor activations

  Baseline, post-training on day 5, and 6 weeks following training

• Raw change in robotic sensorimotor measures

  Baseline, post-training on day 5, and 6 weeks following training

• Raw change in vibro-tactile sensory measures

  Baseline, post-training on day 5, and 6 weeks following training

• Raw change in size of transcranial magnetic stimulation (TMS) motor maps

  Baseline, post-training on day 5, and 6 weeks following training

Other Outcomes (1)

• Tolerability questionnaire

  Baseline, following stimulation daily, and 6 weeks following training

Study Arms (3)

Anodal Conventional tDCS

EXPERIMENTAL

The intervention will be anodal conventional tDCS. Anodal tDCS: 30 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 30 second ramp down to 0 milliamp. Anode positioned over the right primary motor cortex, and the cathode over the contralateral supraorbital area.

Device: Anodal Conventional tDCS

Anodal High Definition tDCS

EXPERIMENTAL

The intervention will be anodal high definition-tDCS. Anodal HD-tDCS: 30 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 30 second ramp down to 0milliamp. Anode entered over the right primary motor cortex, and four cathodes placed in a ring formation surrounding the anode.

Device: Anodal High Definition tDCS

Sham tDCS

SHAM COMPARATOR

Sham subjects will undergo exactly the same anodal conventional tDCS protocol as outlined above. This includes the initial stimulation sequence of ramp up of 30 seconds, generating the initial transient scalp sensations identical to the treatment group. The stimulator will be programmed by the technologist after 120 seconds of stimulation to automatically ramp down to 0milliamp over 30 seconds.

Device: Sham tDCS

Interventions

Anodal Conventional tDCS DEVICE

tDCS will be applied for 20 minutes at 1milliamp while participants are performing a fine motor task. The current will be set at 1milliamp, stimulation will be ramped up over 30 seconds and ramped down over 30 seconds.

Also known as: Direct-current stimulator (Soterix)

Anodal Conventional tDCS

Anodal High Definition tDCS DEVICE

HD-tDCS will be applied for 20 minutes at 1milliamp while participants are performing a fine motor task. The current will be set at 1milliamp, stimulation will be ramped up over 30 seconds and ramped down over 30 seconds.

Also known as: Direct-current stimulator (Soterix)

Anodal High Definition tDCS

Sham tDCS DEVICE

tDCS will be applied for 1 minutes at 1milliamp while participants are performing a fine motor task. The current will be set at 1milliamp, stimulation will be ramped up over 30 seconds and ramped down over 30 seconds.

Also known as: Direct-current stimulator (Soterix)

Sham tDCS

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-18 years
• Right-handed
• Normal development
• No neuropsychiatric disorders, neuropsychotropic medications, or chronic medical conditions
• Informed consent/assent

You may not qualify if:

• Implanted electrical devices, including (but not limited to) cardiac pacemakers.
• Metallic implants or irremovable metal objects
• Pregnant females or females who may be pregnant.
• Braces or upper teeth wires.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Alberta Childrens Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (5)

• Kirton A, Ciechanski P, Zewdie E, Andersen J, Nettel-Aguirre A, Carlson H, Carsolio L, Herrero M, Quigley J, Mineyko A, Hodge J, Hill M. Transcranial direct current stimulation for children with perinatal stroke and hemiparesis. Neurology. 2017 Jan 17;88(3):259-267. doi: 10.1212/WNL.0000000000003518. Epub 2016 Dec 7.

  PMID: 27927938 BACKGROUND

• Ciechanski P, Kirton A. Transcranial Direct-Current Stimulation Can Enhance Motor Learning in Children. Cereb Cortex. 2017 May 1;27(5):2758-2767. doi: 10.1093/cercor/bhw114.

  PMID: 27166171 BACKGROUND

• Kuczynski AM, Semrau JA, Kirton A, Dukelow SP. Kinesthetic deficits after perinatal stroke: robotic measurement in hemiparetic children. J Neuroeng Rehabil. 2017 Feb 15;14(1):13. doi: 10.1186/s12984-017-0221-6.

  PMID: 28202036 BACKGROUND

• Kuczynski AM, Dukelow SP, Semrau JA, Kirton A. Robotic Quantification of Position Sense in Children With Perinatal Stroke. Neurorehabil Neural Repair. 2016 Sep;30(8):762-72. doi: 10.1177/1545968315624781. Epub 2016 Jan 7.

  PMID: 26747126 BACKGROUND

• Cole L, Giuffre A, Ciechanski P, Carlson HL, Zewdie E, Kuo HC, Kirton A. Effects of High-Definition and Conventional Transcranial Direct-Current Stimulation on Motor Learning in Children. Front Neurosci. 2018 Oct 31;12:787. doi: 10.3389/fnins.2018.00787. eCollection 2018.

  PMID: 30429768 DERIVED

Related Links

• Program website

Study Officials

• Adam Kirton, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be assigned to one of three groups (sham, tDCS, HD-tDCS) throughout the duration of the study.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: June 21, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: August 30, 2018
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)