Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Motor Training in PD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02457832
Recruitment Status : Active, not recruiting
First Posted : May 29, 2015
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this research study is to learn more about brain activity when individuals with and without Parkinson disease (PD) move their lower limbs. The investigators also want to see if and how two different types of partnered dance affect brain activity in individuals with and without PD. Testing will take place at the Atlanta VA Medical Center and at Emory University. The investigators expect to enroll about 140 people for this study over a five-year period.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Adapted Tango Dancing Behavioral: Behavioral Control (BC) Condition Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimizing Motor Training in Parkinson Disease Through Neural Mechanisms (NEURODEGEN)
Actual Study Start Date : November 3, 2014
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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.
Behavioral: Adapted Tango Dancing
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.
Behavioral: Adapted Tango Dancing
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.
Behavioral: Behavioral Control (BC) Condition
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.

No Intervention: Normal Control (NC)
Age-matched controls without Parkinson's disease will come in for a single assessment including MRI.



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02457832


Locations
Layout table for location information
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Madeleine E. Hackney, PhD Atlanta VA Medical and Rehab Center, Decatur, GA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02457832    
Other Study ID Numbers: N0870-W
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
Magnetic Resonance Imaging
Neurology
Neurosciences
Physical Medicine
Parkinson Disease
Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases