Aging
Conditions
Keywords
aging, walking, spinal cord, electrical stimulation
Brief summary
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.
Detailed description
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.
Interventions
mild electrical stimulation delivered to lumbosacral spinal cord
mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles
Sponsors
Study design
Masking description
Participants will be masked to the dosage of transcutaneous spinal direct current stimulation (tsDCS)
Intervention model description
Participants will be randomized to one of four different parallel groups
Eligibility
Inclusion criteria
* Preferred 10m walking speed \< 1.0 m/s * Intact tactile sensation based on two-point discrimination * Willingness to be randomized to either intervention and to participate in all aspects of study assessment and intervention
Exclusion criteria
* Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition * spinal cord injury * Alzheimer's * Parkinson's * stroke, etc. * Contraindications to non-invasive spinal stimulation including any prior spinal surgical procedure * Chronic lower back pain * Obesity, defined as Body Mass Index exceeding 30. * This is due to the potential influence of body fat on the amplitude of electrical current flow to the spinal cord. * Use of medications affecting the central nervous system including, but not limited to: * benzodiazepines * anti-cholinergic medication and GABAergic medication * 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 * early stage breast or prostate cancer * Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder * Difficulty communicating with study personnel * including people who cannot speak English * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed Change From Baseline | Measured at session 2 (2 days after the baseline session) | Fastest safe walking speed over the complex walking course (measured as changed between the baseline and follow-up sessions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prefrontal fNIRS Change From Baseline | Measured at session 2 (2 days after the baseline session) | 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) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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 | 5 |
| tsDCS Dosage A and Smooth Insoles tsDCS dosage A and smooth shoe insoles
tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord | 5 |
| tsDCS Dosage B and Smooth Insoles tsDCS dosage B and smooth shoe insoles
tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord | 7 |
| Total | 23 |
Baseline characteristics
| Characteristic | Total | tsDCS Dosage B and Smooth Insoles | tsDCS Dosage A and Smooth Insoles | tsDCS Dosage B and Textured Insoles | tsDCS Dosage A and Textured Insoles |
|---|---|---|---|---|---|
| Age, Continuous | 77.7 years STANDARD_DEVIATION 7.4 | 79.3 years STANDARD_DEVIATION 7.5 | 75.8 years STANDARD_DEVIATION 5.8 | 77.2 years STANDARD_DEVIATION 9.9 | 78.0 years STANDARD_DEVIATION 7.7 |
| Corrected walking speed | .871 meters/second STANDARD_DEVIATION 0.435 | .913 meters/second STANDARD_DEVIATION 0.591 | .819 meters/second STANDARD_DEVIATION 0.388 | .887 meters/second STANDARD_DEVIATION 0.272 | 0.850 meters/second STANDARD_DEVIATION 0.478 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 7 Participants | 5 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 19 Participants | 5 Participants | 4 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 7 |
| other Total, other adverse events | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 7 |
Outcome results
Walking Speed Change From Baseline
Fastest safe walking speed over the complex walking course (measured as changed between the baseline and follow-up sessions)
Time frame: Measured at session 2 (2 days after the baseline session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS Dosage A and Textured Insoles | Walking Speed Change From Baseline | .054 meters/second | Standard Deviation 0.054 |
| tsDCS Dosage B and Textured Insoles | Walking Speed Change From Baseline | .078 meters/second | Standard Deviation 0.04 |
| tsDCS Dosage A and Smooth Insoles | Walking Speed Change From Baseline | .085 meters/second | Standard Deviation 0.04 |
| tsDCS Dosage B and Smooth Insoles | Walking Speed Change From Baseline | .039 meters/second | Standard Deviation 0.12 |
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)
Time frame: Measured at session 2 (2 days after the baseline session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tsDCS Dosage A and Textured Insoles | Prefrontal fNIRS Change From Baseline | -1.21 microMolar | Standard Deviation 0.93 |
| tsDCS Dosage B and Textured Insoles | Prefrontal fNIRS Change From Baseline | 0.24 microMolar | Standard Deviation 1.15 |
| tsDCS Dosage A and Smooth Insoles | Prefrontal fNIRS Change From Baseline | 0.14 microMolar | Standard Deviation 0.47 |
| tsDCS Dosage B and Smooth Insoles | Prefrontal fNIRS Change From Baseline | 0.17 microMolar | Standard Deviation 0.62 |