Parkinson DiseaseNCT02600858
Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease
A study testing Upper limb feeding training in people with Parkinson Disease, run by University of Utah at 1 site in United States.
Trial summary
The study determines whether standard medical care (dopamine) affects learning and retention of an upper limb feeding task in people with Parkinson's disease (PD) and whether training on the feeding task generalises to performance on an untrained upper limb buttoning task. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Upper limb feeding training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease confirmed by neurologist
- Hoehn and Yahr stages 1 to 3
- On a stable dose of antiparkinsonian medication for the past month and will continue on this regime for at least another subsequent month
- Walks unaided
Who cannot join
- Not taking dopamine replacement therapy
- With prior surgical management for PD (e.g. deep brain stimulation)
- With medication-resistant freezing of gait
- Significant cognitive impairment (Montreal Cognitive Assessment score <18)
- Unstable medical conditions
- Other neurological conditions
- Unable to follow instructions or safely complete the training tasks
Trial locations and contacts
1 site in 1 country.
About this study
The study determines whether standard medical care (dopamine) affects learning and retention of an upper limb feeding task in people with Parkinson's disease (PD) and whether training on the feeding task generalises to performance on an untrained upper limb buttoning task. Half the participants will train on the feeding task after they have taken their first dose of dopamine for the day (i.e. "on" medication state), while the other half will train on the same feeding task before taking their first daily dose of dopamine (i.e. "off" medication state).
Read the detailed description
Parkinson disease (PD) is an age related neurodegenerative disorder with symptomatic declines in motor function due to a loss of dopaminergic neurons within the basal ganglia.
Ironically, treatment with exogenous dopamine-replacement medication (e.g. levodopa) may have positive effects on existing motor skills such as handwriting or walking, but may have detrimental effects on the learning of motor skills necessary for effective rehabilitation.
Although dopamine medications are routinely prescribed to replace lost dopamine in the sensorimotor areas of the striatum, they may actually be "overdosing" the associative striatum, a candidate neuroanatomical correlate for motor learning. To date, however, this 'overdose' hypothesis has not been widely tested, given that few studies of motor learning in PD have reported or controlled for whether individuals were tested "on" or "off" their dopamine replacement medication.
- Conditions
- Parkinson Disease
- Being tested
- Upper limb feeding training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb feeding trainingBehavioural
Participants will spoon two raw kidney beans at a time from a center proximal "start" cup to three distal "target" cups positioned 16 cm away at 45°, 90° and 135° around the start cup as fast as possible using their non-dominant hand. Spooning two beans between the start cup and a target cup is considered one repetition; each trial will consist of 15 repetitions. Participants will perform 50 trials per day for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Training "off" medication | Experimental | Participants will train on the upper limb feeding task before taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "off" dopamine replacement medication Receives: Behavioral: Upper limb feeding training |
| Training "on" medication | Other | Participants will train on the upper limb feeding task after taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "on" dopamine replacement medication Receives: Behavioral: Upper limb feeding training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task performance (response time) at initial retention, adjusted for baseline (first trial of acquisition on Day 3)
Measured: Day 8 (i.e. 48 hours after the last block of training)
Secondary outcomes (5)
Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)
Measured: Day 5, Day 8 (i.e. 48 hours after the last block of training)
Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)
Measured: Day 5, Day 15 (i.e. 9 hours after the last block of training)
Rate of improvement
Rate of improvement (c) modelled on the exponential decay function: y = a + be(exp[-x/c]), where a is the final trial time value that the exponential decay function approaches (ie, asymptote), b is the scale of the learning from the first trial time to the value a, x is the trial number, 1/c is the number of trials needed to obtain asymptote (ie, 1 - e-1).
Measured: Day 1 through Day 3
Nine hole peg test score
Time taken to complete the Nine Hole Peg Test at delayed retention, adjusted for baseline (Nine Hole Peg Test score at baseline, i.e. 3 days prior to the first block of training)
Measured: Day 15 (i.e. 9 days after the last block of training)
Buttoning task score
Time taken to complete the Buttoning task at delayed retention, adjusted for baseline (Buttoning task score at baseline, i.e. 3 days prior to the first block of training)
Measured: Day 15 (i.e. 9 days after the last block of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Dibble, University of Utah
- Investigators
- Lee Dibble, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600858
- Sponsor's protocol ID
- IRB_00085073_UL
- Status last verified
- Feb 2018
- First submitted
- 5 Nov 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Reed AM, Duff K, Dibble LE, Paul SS, Hooyman A, Schaefer SY. Examining the Diagnostic Accuracy of a Novel Performance-Based Test for Alzheimer's Disease Screening. J Prev Alzheimers Dis. 2024;11(4):903-907. doi: 10.14283/jpad.2024.93.
PubMed 39044501
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease
- ClinicalTrials.gov ID
- NCT02600858
- Acronym / sponsor ID
- IRB_00085073_UL
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study determines whether standard medical care (dopamine) affects learning and retention of an upper limb feeding task in people with Parkinson's disease (PD) and whether training on the feeding task generalises to performance on an untrained upper limb buttoning task. Half the participants will train on the feeding task after they have taken their first dose of dopamine for the day (i.e. "on" medication state), while the other half will train on the same feeding task before taking their first daily dose of dopamine (i.e. "off" medication state).
Detailed description
Parkinson disease (PD) is an age related neurodegenerative disorder with symptomatic declines in motor function due to a loss of dopaminergic neurons within the basal ganglia.
Ironically, treatment with exogenous dopamine-replacement medication (e.g. levodopa) may have positive effects on existing motor skills such as handwriting or walking, but may have detrimental effects on the learning of motor skills necessary for effective rehabilitation.
Although dopamine medications are routinely prescribed to replace lost dopamine in the sensorimotor areas of the striatum, they may actually be "overdosing" the associative striatum, a candidate neuroanatomical correlate for motor learning. To date, however, this 'overdose' hypothesis has not been widely tested, given that few studies of motor learning in PD have reported or controlled for whether individuals were tested "on" or "off" their dopamine replacement medication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training "off" medication | Experimental | Behavioral: Upper limb feeding trainingParticipants will train on the upper limb feeding task before taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "off" dopamine replacement medication |
| Training "on" medication | Other | Behavioral: Upper limb feeding trainingParticipants will train on the upper limb feeding task after taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "on" dopamine replacement medication |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic Parkinson's disease confirmed by neurologist
- Hoehn and Yahr stages 1 to 3
- On a stable dose of antiparkinsonian medication for the past month and will continue on this regime for at least another subsequent month
- Walks unaided
Key exclusion criteria (7 listed)
- Not taking dopamine replacement therapy
- With prior surgical management for PD (e.g. deep brain stimulation)
- With medication-resistant freezing of gait
- Significant cognitive impairment (Montreal Cognitive Assessment score <18)
- Unstable medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper limb feeding trainingParticipants will spoon two raw kidney beans at a time from a center proximal "start" cup to three distal "target" cups positioned 16 cm away at 45°, 90° and 135° around the start cup as fast as possible using their non-dominant hand. Spooning two beans between the start cup and a target cup is considered one repetition; each trial will consist of 15 repetitions. Participants will perform 50 trials per day for 3 consecutive days. | Behavioural | Training "off" medication, Training "on" medication |
Primary outcome
Task performance (response time) at initial retention, adjusted for baseline (first trial of acquisition on Day 3)
Time frame: Day 8 (i.e. 48 hours after the last block of training)
5 secondary outcomes
Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)
Time frame: Day 5, Day 8 (i.e. 48 hours after the last block of training)
Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)
Time frame: Day 5, Day 15 (i.e. 9 hours after the last block of training)
Rate of improvement
Time frame: Day 1 through Day 3
Nine hole peg test score
Time frame: Day 15 (i.e. 9 days after the last block of training)
Buttoning task score
Time frame: Day 15 (i.e. 9 days after the last block of training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 39044501Reed AM, Duff K, Dibble LE, Paul SS, Hooyman A, Schaefer SY. Examining the Diagnostic Accuracy of a Novel Performance-Based Test for Alzheimer's Disease Screening. J Prev Alzheimers Dis. 2024;11(4):903-907. doi: 10.14283/jpad.2024.93.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Dibble, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb feeding training in people with Parkinson Disease, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task performance (response time) at initial retention, adjusted for baseline (first trial of acquisition on Day 3) (time frame: Day 8 (i.e. 48 hours after the last block of training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02600858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.