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Accelerating Motor Learning in Pediatrics (AMPED)

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ClinicalTrials.gov Identifier: NCT03193580
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Adam Kirton, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Healthy Pediatrics Device: Anodal Conventional tDCS Device: Anodal High Definition tDCS Device: Sham tDCS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to one of three groups (sham, tDCS, HD-tDCS) throughout the duration of the study.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Accelerating Motor Learning in Pediatrics
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anodal Conventional tDCS
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
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.
Other Name: Direct-current stimulator (Soterix)

Experimental: Anodal High Definition tDCS
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
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.
Other Name: Direct-current stimulator (Soterix)

Sham Comparator: Sham tDCS
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
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.
Other Name: Direct-current stimulator (Soterix)




Primary Outcome Measures :
  1. Change in Left Hand Purdue Pegboard Test Score [ Time Frame: Baseline and immediately post-training on day 5 ]
    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.


Secondary Outcome Measures :
  1. Percent change in metabolic markers [ Time Frame: Baseline, post-training on day 5, and 6 weeks following training ]
    Metabolic markers including GABA and glutamate will be assessed using Magnetic Resonance Spectroscopy (MRS). An MRS will be performed at baseline, on day 5 post-training, and at the 6 week follow-up.

  2. Raw change in functional motor activations [ Time Frame: Baseline, post-training on day 5, and 6 weeks following training ]
    Measures of functional motor activity will be assessed using Functional Magnetic Resonance Imaging (MRI). Finger-tapping task will be performed in the MRI scanner. An MRI will be performed at baseline, on day 5 post-training, and at the 6 week follow-up.

  3. Raw change in robotic sensorimotor measures [ Time Frame: Baseline, post-training on day 5, and 6 weeks following training ]
    The Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM). The raw change in measures of proprioception, kinesthesia, visually-guided reaching, and object hit tasks will be measured. On the fifth day, the participants will do a post-training trial.

  4. Raw change in vibro-tactile sensory measures [ Time Frame: Baseline, post-training on day 5, and 6 weeks following training ]
    The raw change of the Brain Gauge vibro-tactile sensory assessment score will be measured. On the fifth day, the participants will do a post-training trial.

  5. Raw change in size of transcranial magnetic stimulation (TMS) motor maps [ Time Frame: Baseline, post-training on day 5, and 6 weeks following training ]
    The raw change in TMS-measured motor evoked potential amplitude (Microvolts,uV) and neurophysiological changes in motor evoked potential size (Microvolts,uV). On the fifth day, the participants will do a post-training trial. Six weeks following the end of training, the participants will perform the task.

  6. Raw change in motor function tasks - Serial Reaction Time test [ Time Frame: Baseline, post-training on day 5, and 6 weeks following training ]
    Raw change in score on the Serial Reaction Time test. A "baseline" trial will be performed. On the fifth day, the participants will do a post-training trial. All tasks are measured in milliseconds. Six weeks following the end of training, the participants will perform the task.

  7. Raw change in motor function tasks - Jebsen-Taylor test [ Time Frame: Baseline, post-training on day 5, and 6 weeks following training ]
    Raw change in score on the Jebsen-Taylor test. A "baseline" trial will be performed. All measures are measured in seconds. On the fifth day, the participants will do a post-training trial. Six weeks following the end of training, the participants will perform the task.

  8. Raw change in motor function tasks - Purdue Pegboard test [ Time Frame: Baseline, post-training on day 5, and 6 weeks following training ]
    Raw change in score on the Purdue Pegboard Test for the left, right, and both hands. A "baseline" trial will be performed. The average number of pegs places will be measured. On the fifth day, they will do a post training trial consisting of 3 repetitions for the left, right, and both hands trials. Six weeks following the end of training, the participants will perform 3 repetitions for the left, right and both hands trials.


Other Outcome Measures:
  1. Tolerability questionnaire [ Time Frame: Baseline, following stimulation daily, and 6 weeks following training ]
    TMS and tDCS safety and tolerability. The questionnaire will be filled out after daily stimulation and at follow-up at 6 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193580


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Alberta Childrens Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Adam Kirton, MD, MSc University of Calgary

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adam Kirton, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT03193580     History of Changes
Other Study ID Numbers: REB16-2474
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adam Kirton, University of Calgary:
Anodal Stimulation Transcranial Direct Current Stimulation
High-Definition Transcranial Direct Current Stimulation
tDCS
Non-invasive brain stimulation
Pediatrics