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Spinal Excitation to Enhance Mobility

Spinal Excitation to Enhance Mobility in Elderly Adults

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03667573
Enrollment
23
Registered
2018-09-12
Start date
2018-12-17
Completion date
2021-08-18
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

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

DEVICEtsDCS Dosage (A)

mild electrical stimulation delivered to lumbosacral spinal cord

DEVICEtsDCS Dosage (B)

mild electrical stimulation delivered to lumbosacral spinal cord

OTHERtextured shoe insoles

textured shoe insoles

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

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

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Walking Speed Change From BaselineMeasured 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

MeasureTime frameDescription
Prefrontal fNIRS Change From BaselineMeasured 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

ArmCount
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
Total23

Baseline characteristics

CharacteristicTotaltsDCS Dosage B and Smooth InsolestsDCS Dosage A and Smooth InsolestsDCS Dosage B and Textured InsolestsDCS Dosage A and Textured Insoles
Age, Continuous77.7 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 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
23 Participants7 Participants5 Participants5 Participants6 Participants
Sex: Female, Male
Female
4 Participants2 Participants1 Participants0 Participants1 Participants
Sex: Female, Male
Male
19 Participants5 Participants4 Participants5 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 50 / 50 / 7
other
Total, other adverse events
0 / 60 / 50 / 50 / 7
serious
Total, serious adverse events
0 / 60 / 50 / 50 / 7

Outcome results

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)

Time frame: Measured at session 2 (2 days after the baseline session)

ArmMeasureValue (MEAN)Dispersion
tsDCS Dosage A and Textured InsolesWalking Speed Change From Baseline.054 meters/secondStandard Deviation 0.054
tsDCS Dosage B and Textured InsolesWalking Speed Change From Baseline.078 meters/secondStandard Deviation 0.04
tsDCS Dosage A and Smooth InsolesWalking Speed Change From Baseline.085 meters/secondStandard Deviation 0.04
tsDCS Dosage B and Smooth InsolesWalking Speed Change From Baseline.039 meters/secondStandard Deviation 0.12
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)

Time frame: Measured at session 2 (2 days after the baseline session)

ArmMeasureValue (MEAN)Dispersion
tsDCS Dosage A and Textured InsolesPrefrontal fNIRS Change From Baseline-1.21 microMolarStandard Deviation 0.93
tsDCS Dosage B and Textured InsolesPrefrontal fNIRS Change From Baseline0.24 microMolarStandard Deviation 1.15
tsDCS Dosage A and Smooth InsolesPrefrontal fNIRS Change From Baseline0.14 microMolarStandard Deviation 0.47
tsDCS Dosage B and Smooth InsolesPrefrontal fNIRS Change From Baseline0.17 microMolarStandard Deviation 0.62

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026