The Role of Methylphenidate on Performance in the Cold

Sponsor
Brock University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04283877
Collaborator
(none)
24
1
2
24.5
1

Study Details

Study Description

Brief Summary

The purpose is to study the effects of dopamine activity, using methylphenidate ingestion, on exercise and cognitive function over the course of a progressive cooling protocol. The investigators hypothesize that methylphenidate will minimize the previously reported impairment in exercise performance and cognitive function with mild hypothermia and cold stress (air temperature: 0˚C) compared to placebo, suggesting that dopamine activity preserves exercise and cognitive capacity with mild hypothermia.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Temperature regulation and decision-making are vital aspects of human survival where relatively small deviations in whole-body heat balance lead to decrements in physical performance and cognitive function. Prolonged exposure to cold stress combined with inadequate clothing and/or insufficient heat production can lead to decreases in body temperature causing mild hypothermia (≤ -1.0˚C in body temperature). Performance in the cold is more physically demanding compared to neutral environments (~22˚C) as there is increased cardiovascular strain due to a strong peripheral vasoconstriction reducing cerebral and muscle blood flow and oxygenation, reduced neuromuscular capacity, as well as changes in energy metabolism during shivering and increased catecholamine release. Additionally, there is an increased psychological strain where perceptually there is a high thermal discomfort, alterations in neurotransmitters (e.g. dopamine, norepinephrine), and alterations in mood. These changes lead to decreases in self-paced cycling time-trial performance in the cold with mild hypothermia compared to thermoneutral environments. Additionally, there appears to be task-dependent cognitive changes with acute cold stress, where higher-order functions such as executive function, working memory, and inhibitory control decrease before simple task performance such as reaction time and visual recognition/awareness. Currently, it is unknown what the potential mechanisms are that lead to these performance decrements.

The decrements in both self-paced exercise and cognitive function may be due to alterations in neurotransmitters caused by hypothermia. Exposure to cold leads to alterations in dopamine, and norepinephrine which may affect prefrontal cortex function, which may explain why higher-order executive function tasks such as inhibitory control and spatial planning are impaired compared to simple task performance. Previously, it has been determined that the use of tyrosine (amino acid precursor to dopamine and norepinephrine neurotransmitters) supplementation improves working memory and executive function despite a -2.0˚C drop in body temperature through cold-water immersion, but not in thermoneutral conditions. However, it is unknown what the role of dopamine or central nervous system stimulants are in the cold. Methylphenidate is a central nervous system stimulant through dopamine re-uptake inhibition is demonstrated to improve executive function task performance in healthy adults in thermoneutral conditions. Additionally, methylphenidate has been demonstrated to improve self-paced cycling performance by 16% in the heat (30˚C) but not thermoneutral environments (1). Methylphenidate is also demonstrated to improve maximal force production during fatiguing exercise, indicating it may play a role in reducing the effects of fatigue during endurance exercise. The investigators aim to determine the role of the central nervous system using methylphenidate on cognitive function and self-paced exercise in the cold.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Single Group AssignmentSingle Group Assignment
Masking:
Single (Investigator)
Masking Description:
Double-blinding of participants and investigator, with independent investigator in charge of placebo and drug
Primary Purpose:
Basic Science
Official Title:
The Role of Methylphenidate on Performance in the Cold
Actual Study Start Date :
Dec 15, 2019
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methylphenidate

30 mg methylphenidate, 60 minutes before testing

Drug: Methylphenidate
3 x 10 mg oral tablets. Single acute dose for all participants

Placebo Comparator: Control

30 mg of lactose pill, 60 minutes before testing

Drug: Placebo oral tablet
3 x 10 mg oral lactose tablet for all participants

Outcome Measures

Primary Outcome Measures

  1. 20 km cycling time trial [2-4 hours post ingestion]

    completion time in minutes

  2. Cognitive function [1-4 hours after ingestion]

    mean reaction time in ms

  3. cognitive function [1-4 hours post ingestion]

    # of errors made

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Males and females
Exclusion Criteria:
  • Diagnosed cardiovascular, respiratory, and/ or neuromuscular disease

  • Prescription of MPH or any drugs for hyperactivity within the past 1 year

  • Diagnosed mental health condition (e.g. depression, anxiety disorder)

  • Raynaud's Disease or Cold Urticaria

  • Current prescription medication (except for asthma or allergy medication)

  • Pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Environmental Ergonomic Laboratory - Brock University St. Catharines Ontario Canada L2S 3A1

Sponsors and Collaborators

  • Brock University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephen Cheung, Professor, Brock University
ClinicalTrials.gov Identifier:
NCT04283877
Other Study ID Numbers:
  • EEL124
First Posted:
Feb 25, 2020
Last Update Posted:
Feb 9, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2021