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The Effects of a Single Dose of Methylphenidate on Motor Performance

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ClinicalTrials.gov Identifier: NCT04283604
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
Tel Aviv University
Wingate Institute
Information provided by (Responsible Party):
Aviva Mimouni-Bloch, Loewenstein Hospital

Brief Summary:

Aim: To evaluate the effects of MPH on young adults diagnosed with ADHD on different exercise performance tests.

Hypothesis: MPH will have positive effects on motor tests requiring concentration.

Methods: 200 healthy physical education students, 100 participants diagnosed with ADHD will serve as the treatment group and 100 non-ADHD diagnosed will serve as a control group. The study will be divided into two sub studies (100 participants each), in which, two motor tests will be evaluated (two agility tests and two motor accuracy tests).

All participants will arrive for two sessions, and will perform two motor tests in each session. In the second session, half of the participants with ADHD (25 participants) will undergo another session of the same motor tests with their usual treatment (treatment group) and another half (25 participants) without their treatment (ADHD control group). The non-ADHD control group (50 participants) will perform the second session without medications - to assess a learning effect.

Note, we are not planning on giving the medication to the participant, rather he/she will consume their own prescribed MPH by them self. Control treatment for ADHD participants will consist of not taking their medication before the motor test.

For evaluation of physiological responses and perception of effort we will measure heart rate, temperature, blood pressure and RPE before and after motor tests.


Condition or disease Intervention/treatment Phase
ADHD Drug: MPH Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study will be divided into two sub studies (100 participants each), in which 50 ADHD and 50 non-ADHD participants will be included. In the first session, all participants will undergo motor tests, in the same conditions. In the second session, half of ADHD participants (25) will be asked to take their regular MPH treatment, before the session. All other participants (25 ADHD and 50 non-ADHD) will perform the motor tests without treatment, and serve as control groups.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of a Single Dose of Methylphenidate on Motor Performance
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADHD with MPH
ADHD participants, taking MPH before the second session
Drug: MPH
The treatment will include taking the patient's own medication by the patient himself in the treatment session 60-180 minutes before the beginning of the tests, according to their prescription given by their own physician. Participants must have consumed this medication at least 3 months before the first session as their regular treatment for ADHD. Note, we are not planning on giving the medication to the participant, rather he/she will consume their own prescribed MPH by them self.
Other Names:
  • Concerta
  • Ritalin

No Intervention: ADHD no MPH
ADHD participants will perform motor tests in both session, without any intervention, for evaluation of learning effect among ADHD participants.
No Intervention: Healthy participants
Non-ADHD participants will serve as a control group for learning effect on motor tests



Primary Outcome Measures :
  1. Agility tests [ Time Frame: 2 min ]
    Two agility tests (Zigzag with and without a ball) will be performed. The best time of each test will be recorded. Calculation of the ratio of zigzag test without the ball and with the ball will be conducted

  2. Accuracy motor tests [ Time Frame: 10 min ]
    Two accuracy motor tests (the stationary free throw shooting test and the dynamic 60-second free throw shooting test) will be performed three times. The average scores of the all three trials will be used for analysis.


Secondary Outcome Measures :
  1. Blood pressure (BP) [ Time Frame: 1 min X 2 times ]
    BP will be measured before and after motor test by using a mercury sphygmomanometer.

  2. Body Temperature [ Time Frame: 1 min X 2 times ]
    body temperature will be measured sublingually at the beginning and at the end of each motor test using an electronic thermometer

  3. Heart rate (HR) [ Time Frame: Continuously for 10 min ]
    Heart rates will be continuously recorded throughout the test (Polar heart rate monitor S 710). HR before and after the tests will be recorded

  4. Rate of Perceived exertion (RPE) scale [ Time Frame: 10 sec X 2 times ]
    To measure subjective sense of effort we will use the Borg rate of perceived exertion (RPE) scale (ranges from 6 to 20) at the end of each motor test.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Students age 18-45 years old studying at the academic college at Wingate. For the treatment group we will recruit students who were previously diagnosed by a neurologist or psychiatrist or other ADHD physician specialist as having ADHD, and are treated with a methylphenidate (Ritalin; Ritalin SR; Ritalin LA; Concerta) at least 3 months before the first session. Control group will consist of students without ADHD.

Exclusion Criteria:

any chronic illness other than ADHD (e.g. asthma, gastrointestinal, depression, anxiety, etc.), taking chronic medications apart from stimulant therapy.


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): NCT04283604


Contacts
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Contact: Aviva Mimouni-Bloch, MD 7709085 ext 972 9 abloch@clalit.org.il

Sponsors and Collaborators
Loewenstein Hospital
Tel Aviv University
Wingate Institute
Publications:
Meckel Y, Nemet D, Eliakim A. the Effect of Methylphenidate Treatment on Exercise Performance in Children With Attention-Deficit Hyperactivity Disorder. Acta Kinesiol. Univ. Tartu 7:109-16, 2011
Pojskic H, Muratovic M. The relationship between physical fitness and shooting accuracy of professional basketball players 20:1-13, 2014

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Responsible Party: Aviva Mimouni-Bloch, Head of child developmental center, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT04283604    
Other Study ID Numbers: 0007-19-LOE
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Aviva Mimouni-Bloch, Loewenstein Hospital:
Concerta
Physical Activity
Motor test
Exercise
Ritalin
Additional relevant MeSH terms:
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Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents