Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000075987p
Ethics application status
Not yet submitted
Date submitted
8/01/2020
Date registered
30/01/2020
Date last updated
30/01/2020
Date data sharing statement initially provided
30/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the role of dopamine on exercise and motor learning in healthy young adults
Scientific title
The role of dopamine: Investigating the impact of Sulpiride exposure on exercise-related enhancement of motor skill learning in healthy volunteers.
Secondary ID [1] 300065 0
None
Universal Trial Number (UTN)
U1111-1245-2562
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 315588 0
Dopamine depletion 315595 0
Condition category
Condition code
Mental Health 313875 313875 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 314196 314196 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug intervention: A single dose of 600mg of Sulpiride administered in one testing session via oral capsule.
Exercise intervention: A 20 minute bout of high-intensity exercise on a stationary bicycle. It will take place 1-2 hours after sulpiride administration to ensurure maximum dose saturation. Exercise will be targeted at between 50% and 90% of the participants' estimated maximum heart rate to ensure appropriate intensity. This will be delivered by (or under the supervision of) Eleanor Taylor, PhD candidate with 2 years experience administering similar exercise interventions in participants aged 18 to 75 years, or Dr James Coxon, the head of the Movement and Exercise Neuroscience laboratory at Monash University with >10 years experience in research focused on cognitive neuroscience and exercise. All exercise will be undertaken in the Neurophysiology Suite at Monash University.
A wash out period of approximately 1 week will occur between drug and placebo sessions.
Intervention code [1] 316334 0
Treatment: Drugs
Intervention code [2] 316336 0
Lifestyle
Comparator / control treatment
Drug intervention: A single dose of A gelatin filled placebo capsule administered in one testing session via oral capsule.
Exercise intervention: A 20 minute bout of high-intensity exercise on a stationary bicycle, as described above.
Order of placebo/Sulpiride administration will be counterbalanced among participants.
Control group
Placebo

Outcomes
Primary outcome [1] 322262 0
Change in the observed impact of exercise on motor skill retention.
This will be assessed by examining change in the "skill" measure on the Sequential Visual Isometric Pinch Task before and after a 7 day consolidation period. This incorporates both speed and accuracy on the motor task. This information is collected electronically via a force transducer and a customised program in Labview,
Timepoint [1] 322262 0
7 days after drug and exercise intervention
Primary outcome [2] 322277 0
Change in observed motor skill learning.
This will be assessed by examining change in the "skill" measure on the Sequential Visual Isometric Pinch Task across the duration of task learning blocks. This incorporates both speed and accuracy on the motor task. This information is collected electronically via a force transducer and a customised program in Labview,
Timepoint [2] 322277 0
3 hours after administration of drug (5-10 minutes after exercise intervention)
Primary outcome [3] 322278 0
Adverse reactions to the drug as measured by the Bond-Lader Visual Analogue Scales. Possible temporary side effects of sulpiride, which should progressively disappear as the drug is cleared from the bloodstream, include drowsiness, restlessness, muscle contractions of the head, neck, trunk and limbs causing stiffness and resistance to movement in joints, slowness of movement and tremors
Timepoint [3] 322278 0
Administered at baseline and every 1 hour during the experimental sessions
Secondary outcome [1] 377911 0
A composite measure of alertness and well-being levels as measured using the Bond-Lader Visual Analogue Scales
Timepoint [1] 377911 0
Administered at baseline and every 1 hour during the experimental sessions

Eligibility
Key inclusion criteria
Healthy young adults, male and female.
Females taking combined oral contraceptive pill - to control for any differing absorption rates that may be the result of fluctuating hormones.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant or breastfeeding - to prevent any potential risk of harm Sulpiride may cause for unborn or newborn children
- History of psychiatric or neurological illness (including head injuries) - such conditions may confound results
- Use of psychotropic medication or significant drug use - could confound results, as any possible alteration in brain function from previous drug use may interfere with substances administered in this study
- Alcohol dependence (more than 24 units/week) - may influence dopamine receptor availability or sensitivity
- Individuals with contraindications to Sulpiride

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation of allocation to drug or placebo groups is done externally through an off-site organisation and concealed to the participants and the researcher until completion of data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2020
Actual
Date of last participant enrolment
Anticipated
14/10/2020
Actual
Date of last data collection
Anticipated
28/10/2020
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304516 0
University
Name [1] 304516 0
Monash University
Country [1] 304516 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 304845 0
None
Name [1] 304845 0
Address [1] 304845 0
Country [1] 304845 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304947 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 304947 0
Ethics committee country [1] 304947 0
Australia
Date submitted for ethics approval [1] 304947 0
03/02/2020
Approval date [1] 304947 0
Ethics approval number [1] 304947 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98730 0
Dr James Coxon
Address 98730 0
Monash University, Wellington Road, Clayton, VIC, 3800
Country 98730 0
Australia
Phone 98730 0
+613 99020320
Fax 98730 0
Email 98730 0
[email protected]
Contact person for public queries
Name 98731 0
Eleanor Taylor
Address 98731 0
Monash University, Wellington Road, Clayton, VIC, 3800
Country 98731 0
Australia
Phone 98731 0
+613 99051561
Fax 98731 0
Email 98731 0
[email protected]
Contact person for scientific queries
Name 98732 0
James Coxon
Address 98732 0
Monash University, Wellington Road, Clayton, VIC, 3800
Country 98732 0
Australia
Phone 98732 0
+613 99020320
Fax 98732 0
Email 98732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.