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| ID | Type | Description | Link |
|---|---|---|---|
| I21RX002874 | U.S. NIH Grant/Contract | View source |
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Older adults with compromised walking ability have higher rates of morbidity and mortality, more hospitalizations, poorer quality of life, and are less likely to remain independent in the community. It is known that age-related changes in brain and peripheral nerves contribute to loss of walking ability. However, there is a lack of research into how the aging spinal cord affects walking. In older adults, the spinal cord is less excitable, conducts signals more slowly, and is subject to neural noise. Intervening on age-related impairment of the spinal cord to improve walking ability is a very promising but untapped area of research.
It is well known that age-related impairments of the brain and peripheral nerves contribute to a decline in walking function. Age-related impairment of the spinal cord is also a likely contributing factor, as the literature describes a variety of changes in spinal cord structure and function with aging. Specifically, the elderly spinal cord is less excitable, conducts signals more slowly, and is subject to neural noise. Therefore, the investigators are initiating a new line of research with the goal of enhancing walking function in older adults by intervening on age-related neural impairment of the spinal cord. The objective of the proposed study is to establish the feasibility, preliminary efficacy, and variance of response for using transcutaneous spinal direct current stimulation (tsDCS) and textured shoe insoles to excite spinal locomotor circuits and enhance practice-related performance and retention on an obstacle walking task. Enhanced practice and retention effects will support future efforts to translate this approach into a longer term rehabilitation intervention.
Excitatory tsDCS is a non-invasive neuromodulation approach in which a relatively weak electrical current is delivered to the desired region of the spinal cord via electrodes placed on the skin. The electrical current does not cause discharge of action potentials, but rather is designed to bring neurons closer to their discharge threshold by inducing a sub-threshold depolarization of membrane potentials. When combined with a behavioral task, tsDCS has the potential to upregulate neural circuits in a task-specific manner and promote Hebbian neuroplasticity ('fire together, wire together'). The investigators will use a previously established electrode montage to deliver excitatory tsDCS to the lumbosacral spinal cord during practice of a complex obstacle walking task. The investigators also propose to combine the use of textured shoe insoles with tsDCS. This combinatorial approach may be a potent strategy for simultaneously optimizing spinal responsiveness to input from both descending and ascending excitatory signals to spinal centers of locomotor control. The investigators propose a parallel groups study design in which 40 older adults who have walking deficits and who demonstrate a compensatory executive locomotor control strategy will be randomized into one of four groups: 1) dosage "A" tsDCS with smooth insoles (active/smooth); 2) dosage "B" tsDCS with smooth insoles (sham/smooth); 3) dosage "A" tsDCS with textured insoles (active/textured); and 4) dosage "B" tsDCS with textured insole (sham/textured). Participants will be blinded to group assignment. While receiving stimulation, participants will engage in walking practice over a standardized obstacle course. Immediately prior to and following the practice, each participant will be assessed while walking over the course. Practice-related gains in performance will be quantified primarily by fastest safe walking speed. Retention of performance gains will also be assessed at a separate later visit. Intervening on age-related impairment of the spinal cord to improve walking function is a promising but untapped area of research. The proposed intervention techniques are low cost and translatable to real-world settings, which enhances the potential long term impact of this work on the well-being of older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tsDCS Dosage A and textured insoles | Experimental | tsDCS dosage "A" and textured shoe insoles |
|
| tsDCS Dosage B and textured insoles | Experimental | tsDCS dosage "B" and textured shoe insoles |
|
| tsDCS Dosage A and smooth insoles | Experimental | tsDCS dosage "A" and smooth shoe insoles |
|
| tsDCS Dosage B and smooth insoles | Experimental | tsDCS dosage "B" and smooth shoe insoles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tsDCS Dosage (A) | Device | mild electrical stimulation delivered to lumbosacral spinal cord |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking Speed Change From Baseline | Fastest safe walking speed over the complex walking course (measured as changed between the baseline and follow-up sessions) | Measured at session 2 (2 days after the baseline session) |
| Measure | Description | Time Frame |
|---|---|---|
| Prefrontal fNIRS Change From Baseline | Prefrontal brain activity while walking at fastest safe walking speed over the complex walking course (measured by fNIRS as change between baseline and follow-up session) | Measured at session 2 (2 days after the baseline session) |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition
Contraindications to non-invasive spinal stimulation including any prior spinal surgical procedure
Chronic lower back pain
Obesity, defined as Body Mass Index exceeding 30.
Use of medications affecting the central nervous system including, but not limited to:
Severe arthritis, such as awaiting joint replacement
Current cardiovascular, lung or renal disease
Diabetes
Terminal illness
Myocardial infarction or major heart surgery in the previous year
Cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis
Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
Difficulty communicating with study personnel
Uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
Bone fracture or joint replacement in the previous six months
Current participation in physical therapy for lower extremity function or cardiopulmonary rehabilitation
Current enrollment in any clinical trial
Planning to relocate out of the area during the study period
Clinical judgment of investigative team
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| Name | Affiliation | Role |
|---|---|---|
| David J. Clark, DSc | North Florida/South Georgia Veterans Health System, Gainesville, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35309891 | Result | Clark DJ, Hawkins KA, Winesett SP, Cox BA, Pesquera S, Miles JW, Fuller DD, Fox EJ. Enhancing Locomotor Learning With Transcutaneous Spinal Electrical Stimulation and Somatosensory Augmentation: A Pilot Randomized Controlled Trial in Older Adults. Front Aging Neurosci. 2022 Mar 2;14:837467. doi: 10.3389/fnagi.2022.837467. eCollection 2022. |
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A Limited Dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
The Limited Dataset will be available after the study is completed.
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Participants were excluded if they had major health conditions that would affect their safety in the study and/or their ability to perform the study procedures (e.g., ability to walk independently). Other exclusion criteria were excessive body mass index, major somatosensory impairment of the feet, and use of medications affecting the central nervous system.
Study advertisements were mailed to patients of the North Florida/South Georgia Veterans Health System using a mailing list generated by the VA Informatics and Computing Infrastructure. Inclusion criteria for recruitment mailings included age 65 or greater, primary residence in a local zip code, and absence of major medical conditions (based on ICD-9/ICD-10 codes). A screening questionnaire was used to interview individuals by telephone prior to scheduling an onsite screening visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | tsDCS Dosage A and Textured Insoles | tsDCS dosage "A" and textured shoe insoles tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord textured shoe insoles: textured shoe insoles |
| FG001 | tsDCS Dosage B and Textured Insoles | tsDCS dosage "B" and textured shoe insoles tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord textured shoe insoles: textured shoe insoles |
| FG002 | tsDCS Dosage A and Smooth Insoles | tsDCS dosage "A" and smooth shoe insoles tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord |
| FG003 | tsDCS Dosage B and Smooth Insoles | tsDCS dosage "B" and smooth shoe insoles tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | tsDCS Dosage A and Textured Insoles | tsDCS dosage "A" and textured shoe insoles tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord textured shoe insoles: textured shoe insoles |
| BG001 | tsDCS Dosage B and Textured Insoles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Speed Change From Baseline | Fastest safe walking speed over the complex walking course (measured as changed between the baseline and follow-up sessions) | Posted | Mean | Standard Deviation | meters/second | Measured at session 2 (2 days after the baseline session) |
|
3 days
An adverse event is any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's involvement in the research, whether or not considered related to participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tsDCS Dosage A and Textured Insoles | tsDCS dosage "A" and textured shoe insoles tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord textured shoe insoles: textured shoe insoles |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Clark | Malcom Randall VA Medical Center | 352-376-1611 | 105244 | davidclark@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2021 | Aug 20, 2022 | Prot_SAP_000.pdf |
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Participants will be randomized to one of four different parallel groups
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Participants will be masked to the dosage of transcutaneous spinal direct current stimulation (tsDCS)
| tsDCS Dosage (B) | Device | mild electrical stimulation delivered to lumbosacral spinal cord |
|
| textured shoe insoles | Other | textured shoe insoles |
|
tsDCS dosage "B" and textured shoe insoles tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord textured shoe insoles: textured shoe insoles |
| BG002 | tsDCS Dosage A and Smooth Insoles | tsDCS dosage "A" and smooth shoe insoles tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord |
| BG003 | tsDCS Dosage B and Smooth Insoles | tsDCS dosage "B" and smooth shoe insoles tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Corrected walking speed | Mean | Standard Deviation | meters/second |
|
| OG002 | tsDCS Dosage A and Smooth Insoles | tsDCS dosage "A" and smooth shoe insoles tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord |
| OG003 | tsDCS Dosage B and Smooth Insoles | tsDCS dosage "B" and smooth shoe insoles tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord |
|
|
| Secondary | Prefrontal fNIRS Change From Baseline | Prefrontal brain activity while walking at fastest safe walking speed over the complex walking course (measured by fNIRS as change between baseline and follow-up session) | Posted | Mean | Standard Deviation | microMolar | Measured at session 2 (2 days after the baseline session) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | tsDCS Dosage B and Textured Insoles | tsDCS dosage "B" and textured shoe insoles tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord textured shoe insoles: textured shoe insoles | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | tsDCS Dosage A and Smooth Insoles | tsDCS dosage "A" and smooth shoe insoles tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | tsDCS Dosage B and Smooth Insoles | tsDCS dosage "B" and smooth shoe insoles tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord | 0 | 7 | 0 | 7 | 0 | 7 |
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