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Trial record 26 of 158 for:    Recruiting, Not yet recruiting, Available Studies | NIA

Combining tDCS and Neurorehabilitation to Treat Age-related Deficits of Mobility and Cognition: UPfront Walking Study

This study is currently recruiting participants.
Verified November 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT03122236
First Posted: April 20, 2017
Last Update Posted: November 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida
  Purpose
Loss of mobility and cognitive ability are serious conditions that threaten the independence of older adults. The objective of this study is to initiate a line of research to develop a novel therapeutic intervention to enhance both mobility and cognition via neuroplasticity of frontal/executive circuits.

Condition Intervention
Mobility Limitation Cognitive Impairment Behavioral: Neurorehabilitation of Standard Walking Behavioral: Neurorehabilitation of Complex Walking Device: Transcranial Direct Current Stimulation (tDCS) dosage A Device: Transcranial Direct Current Stimulation (tDCS) dosage B

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will take part in a 6-week, 18-session neurorehabilitation led by qualified and trained study personnel. Participants will be randomized to one of three groups: 1) standard walking neurorehabilitation with sham tDCS ('standard/sham' group), 2) complex walking neurorehabilitation with sham tDCS ('complex/sham' group), or 3) complex walking neurorehabilitation with active anodal tDCS ('complex/active' group). Training logs will be maintained to gauge the content and intensity of training.
Masking: Double (Participant, Investigator)
Masking Description:
. To control for intensity, participants will maintain a rating of perceived exertion of 4 (moderate to strong) on the Borg Category/Ratio Scale during walking. Exertion will be adjusted by modifying walking speed and/or by modifying the rest time between walking bouts.
Primary Purpose: Treatment
Official Title: Combining tDCS and Neurorehabilitation to Treat Age-related Deficits of Mobility and Cognition: UPfront Walking Study

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Mobility: Figure-of-eight walking test (Figure-8 Walk Test) [ Time Frame: Baseline to 6 weeks ]
    Time to complete a walking course at usual pace. The course is 15 feet in length and arranged as a Figure-8 pattern.


Secondary Outcome Measures:
  • Cognitive Composite executive score on NIH EXAMINER battery (EXAMINER) [ Time Frame: Baseline to 6 weeks ]
    A battery of assessments that tests 7 domains of executive function separately and as a composite score.

  • Adherence to interventions [ Time Frame: Baseline to 6 weeks ]
    number of sessions attended

  • Retention of participants [ Time Frame: Baseline to 6 weeks ]
    number of participants completing rehabilitation and post-therapy assessment

  • Adverse events in each study arm [ Time Frame: 3 month ]
    Number of unexpected and/or serious adverse events

  • Changes in prefrontal/executive activity during performance of the Figure-8 Walk Test [ Time Frame: Baseline to 6 weeks ]
    Assesses the change in demand for executive control resources during walking.

  • Changes in prefrontal/executive activity during performance EXAMINER test to probe mechanisms of response [ Time Frame: Baseline to 6 weeks ]
    Assesses the change in demand for executive control resources cognitive/executive tasks.


Estimated Enrollment: 35
Actual Study Start Date: June 1, 2017
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard walking with tDCS dosage A
Neurorehabilitation of Standard Walking and Transcranial Direct Current Stimulation (tDCS) dosage A
Behavioral: Neurorehabilitation of Standard Walking
Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking.
Device: Transcranial Direct Current Stimulation (tDCS) dosage A
tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
Other Name: Soterix Direct Current Stimulator
Active Comparator: Complex walking with tDCS dosage A
Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage A
Behavioral: Neurorehabilitation of Complex Walking
Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Device: Transcranial Direct Current Stimulation (tDCS) dosage A
tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
Other Name: Soterix Direct Current Stimulator
Active Comparator: Complex walking with tDCS dosage B
Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage B
Behavioral: Neurorehabilitation of Complex Walking
Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Device: Transcranial Direct Current Stimulation (tDCS) dosage B
tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
Other Name: Soterix Direct Current Stimulator

Detailed Description:

Frontal lobe dysfunction has been implicated as a factor contributing to gait deficits in some individuals with Alzheimer's disease, frontotemporal dementia and vascular dementia. There is a critical gap in knowledge about what therapeutic strategies are effective for maintaining or reinstating function in this critical brain region in order to preserve physical and cognitive health in older adults. The goal of our research is to develop a novel therapeutic intervention to enhance both mobility and cognition via neuroplasticity of frontal/executive control circuits. The Investigator will engage neuroplasticity of frontal circuits in two ways. The first is through neurorehabilitation with "complex walking tasks" (CWTs), such as obstacle crossing, obstacle avoidance and walking on non-uniform surfaces. CWTs are a potent behavioral approach for engaging prefrontal circuits. Furthermore, CWTs are crucial to successful ambulation in the home and community settings and therefore provide an ecologically valid therapeutic approach. The second approach that the Investigator will use to engage neuroplasticity of frontal circuits is anodal transcranial direct current stimulation (tDCS). Anodal tDCS is a safe, non-invasive neuromodulation technique. It has previously been shown to induce excitatory effects on brain tissue and, in single-session assessments, to improve performance during complex walking tasks. tDCS has also been shown to be an effective adjuvant for enhancing the effects of cognitive training. The objective of this study is to calculate effect size, establish variance of response and demonstrate feasibility of the experimental interventions in order to plan for a full scale clinical trial. Participants will include thirty older adults who demonstrate evidence of frontal/executive impairment. Participants will be randomized to one of three groups: 1) standard walking neurorehabilitation with sham tDCS ('standard/sham' group), 2) complex walking neurorehabilitation with sham tDCS ('complex/sham' group), or 3) complex walking neurorehabilitation with active anodal tDCS ('complex/active' group). Functional near infrared spectroscopy (fNIRS) will be used to explore intervention-induced changes in prefrontal cortical activity. Assessments will be conducted at baseline, post-treatment and 3-month follow up. The Investigator propose the following specific aims:

Specific Aim 1: Determine preliminary efficacy for recovery of mobility and cognitive function.

Specific Aim 2: Demonstrate feasibility/safety of tDCS as an adjuvant to rehabilitation.

Specific Aim 3: Explore the relationship between prefrontal activity and behavioral outcomes The data collected here will provide the information needed to justify and plan a future full scale clinical trial to assess the relative efficacy and underlying mechanisms of each intervention approach.

  Eligibility

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.


Ages Eligible for Study:   65 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • preferred 10m walking speed < 1.0 m/s
  • 40th-80th percentile rank (age and education corrected score) on NIH toolbox executive assessments: Card Sort Test and Flanker test
  • Willingness to be randomized to either intervention and to participate in all aspects of study assessment and intervention

Exclusion criteria

  • Contraindications to non-invasive brain stimulation and/or MRI including metal in the head, pacemaker, known abnormal cranial fissures/holes.
  • difficulty communicating with study personnel
  • uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
  • Low vision that cannot be corrected by wearing glasses. Low visual will be operationally defined as visual acuity less than 20/70 on a standard eye chart, or difficulty performing complex walking tasks due to visual conditions affecting accurate navigation around and over obstacles (self-reported or observed by examiner).
  • illiterate, due to the likelihood of difficulties performing some of the cognitive tasks
  • non-English speaking, due to the likelihood of difficulties following instructions during therapy and during assessments
  • clinical judgment of investigative team
  Contacts and Locations
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): NCT03122236


Contacts
Contact: David Clark, ScD 352-376-1611 ext 5244 davidclark@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
Principal Investigator: David Clark, ScD University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03122236     History of Changes
Other Study ID Numbers: IRB201602317 -N
First Submitted: April 7, 2017
First Posted: April 20, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cognitive Dysfunction
Mobility Limitation
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Signs and Symptoms