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

Not Applicable

Completed

• Conditions: Mobility Limitation; Cognitive Impairment
• Interventions: Behavioral: Neurorehabilitation of Standard Walking; Behavioral: Neurorehabilitation of Complex Walking; Device: Active Transcranial Direct Current Stimulation (Active tDCS); Device: Sham Transcranial Direct Current Stimulation (Sham tDCS)

• Registration Number: NCT03122236
• Lead Sponsor: University of Florida

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Study Start: 2017-06-01
• Primary Completion: 2020-05-31
• Study Completion: 2021-03-06
• Results First Submitted: 2024-02-23
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Results First Posted: 2024-06-14
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complex walking with Active tDCS	Active Transcranial Direct Current Stimulation (Active tDCS)	Neurorehabilitation of Complex Walking and Active Transcranial Direct Current Stimulation (Active tDCS)
Standard walking with Sham tDCS	Neurorehabilitation of Standard Walking	Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Complex walking with Sham tDCS	Neurorehabilitation of Complex Walking	Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Standard walking with Sham tDCS	Sham Transcranial Direct Current Stimulation (Sham tDCS)	Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Complex walking with Sham tDCS	Sham Transcranial Direct Current Stimulation (Sham tDCS)	Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Complex walking with Active tDCS	Neurorehabilitation of Complex Walking	Neurorehabilitation of Complex Walking and Active Transcranial Direct Current Stimulation (Active tDCS)

Primary Outcome Measures

Name	Time	Method
Mobility: Figure-of-eight Walking Test (Figure-8 Walk Test)	Change (value at 6 weeks minus value at baseline)	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

Name	Time	Method
Cognitive Composite Executive Score on EXAMINER Battery	Change (value at 6 weeks minus value at baseline)	EXAMINER is an acronym for "Executive Abilities:Measures and Instruments for Neurobehavioral Evaluation and Research.; EXAMINER is a battery of assessments that tests 7 domains of executive function separately and as a composite score. The composite score is based on Item Response Theory (logistic modeling) and ranges from a minimum value of -4 to a maximum value of 4. Higher scores indicate better performance.

Trial Locations

Locations (3)

UF Institute on Aging; 🇺🇸 Gainesville, Florida, United States

HealthStreet; 🇺🇸 Gainesville, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States