- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02457832
Motor Training in PD
Optimizing Motor Training in Parkinson Disease Through Neural Mechanisms (NEURODEGEN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Persons with Parkinson's disease (PD) have impaired mobility, which adversely affects their quality of life. The effectiveness of adapted tango dance, in which participants both lead (internally guide: IG) and follow (externally guide: EG) movement has been shown. To improve outcomes in those with PD, the underlying brain mechanisms for both motor impairments and improvement must be studied. IG and EG movements have distinct brain activity patterns. Individuals with PD have trouble with IG movement but this problem is helped by strategies used while "leading." During "following", participants with PD can use many external cues, which helps movement in PD, because EG tasks bypass the basal ganglia, the part of the brain affected by PD. In older persons with PD, the investigators aim to:
- determine brain activation patterns during IG and EG foot movement.
- look into effects of IG and EG training on brain activation along with mobility improvements.
The investigators will begin with a functional Magnetic Resonance Imaging test in a scanner. The investigators will look at brain area correlates of a clinically-used foot-tapping task, during IG and EG conditions in older persons with and without PD. Then, the investigators will assess the relative effectiveness of IG versus EG training during an adapted tango class, compared to a group that participates in health education, for improved mobility and foot tapping. Participants with PD will be assessed for disease severity. They will receive tests of outcome measures while "OFF" and "ON" PD-specific medications at the following time points:
- 1 week before training
- 1 week after training
- 1 month after training Participants must attend 20 lessons of IG or EG adapted tango in 12 weeks, taught by an experienced instructor. In the functional MRI (fMRI) scanner, the investigators will assess participants for improved foot tapping after training. The investigators will also look at changes in activation in specific brain circuits along with training effects upon mobility.
The long-term goal is to improve motor training as much as possible for persons with PD by understanding foot movement brain circuitry in PD as well as brain changes in circuitry through which training is effective. This work proposes to illumine information about brain function that is very important to continued progress in rehabilitative care of persons with PD.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Georgia
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Decatur, Georgia, United States, 30033-4004
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 40 - 70 years
- Willingness to spend 1-h in a scanner
- Able to walk with or without an assistive device 10 feet
- Best corrected/aided acuity better than 20/70 in the better eye
- Absence of dementia or vascular cognitive impairment
- Absence of primary memory deficits
Exclusion Criteria:
- Deep brain stimulator implants, Metallic implants, fragments, or pacemakers
- Montreal Cognitive Assessment (MocA) score < 24
- Pure-tone threshold sensitivity > 40 dB
- Peripheral neuropathy
- Untreated Major Depression
- History of stroke, or traumatic brain injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internal guidance training (IG)
Adapted tango dancing is a sophisticated, yet accessible system of tactile communication that conveys motor intentions and goals between a leader and follower.
Those in IG training will choose direction, timing and amplitude of each successive step, and will communicate this information to their partner through moving their frame and center of mass.
|
Composed of simple steps, tango involves frequent movement initiation and cessation, multi-directional perturbations and varied rhythms.
Participants focus on trunk control and stepping strategies, coordination, somatosensory awareness, attention to partner, path of movement, and aesthetics.
Sessions will begin with a typical dance class warm-up consisting of breathing, limbering and postural alignment to upbeat music.
Novel step elements will be introduced every class period.
Those with PD will partner with an individual without PD.
After novel step introduction, the instructor will present rhythmic training, which is indispensable to partnered dancing.
Participants will learn 'typical' rhythms from tango and Latin dances, based upon the system of quicks (Q) and slows (S), ubiquitously used in ballroom dance training to understand the temporal relationship of movement to music.
|
Experimental: Externally guided training (EG)
Those in EG will learn to attend to sensory cues for movement direction, timing and amplitude of steps, communicated from their partner to them via the frame and center of mass.
The 'follower' will wait to receive the movement cue before moving.
|
Composed of simple steps, tango involves frequent movement initiation and cessation, multi-directional perturbations and varied rhythms.
Participants focus on trunk control and stepping strategies, coordination, somatosensory awareness, attention to partner, path of movement, and aesthetics.
Sessions will begin with a typical dance class warm-up consisting of breathing, limbering and postural alignment to upbeat music.
Novel step elements will be introduced every class period.
Those with PD will partner with an individual without PD.
After novel step introduction, the instructor will present rhythmic training, which is indispensable to partnered dancing.
Participants will learn 'typical' rhythms from tango and Latin dances, based upon the system of quicks (Q) and slows (S), ubiquitously used in ballroom dance training to understand the temporal relationship of movement to music.
|
Active Comparator: Behavioral Control (BC)
BC participants will attend group health education sessions adapted to the needs of individuals with PD, about pharmacological management, nutrition, sleep disorders, cognitive deficits, bereavement coping, mobility, balance and home safety.
Participants in this training will be instructed not to change their habitual exercise routines.
After completing health education, participants will be assigned to an IG or EG training class but will not undergo evaluations.
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Group health education sessions adapted to the needs of individuals with PD, about pharmacological management, nutrition, sleep disorders, cognitive deficits, bereavement coping, mobility, balance and home safety.
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No Intervention: Normal Control (NC)
Age-matched controls without Parkinson's disease will come in for a single assessment including MRI.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent signal change
Time Frame: 12 weeks
|
For the IG and EG tasks for the MRI, the investigators want to determine and distinguish circuits involved in IG and EG foot-tapping networks in participants with and without PD.
|
12 weeks
|
Connectivity strength
Time Frame: 12 weeks
|
Changes in average connectivity strength across striatal-thalamo-cortical (STC) and cerebello-thalamo-cortical (CTC) circuits, as measured by average cross correlation coefficient between the seed regions of the circuits.
|
12 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N0870-W
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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