AgingPhase 1NCT03667573
Spinal Excitation to Enhance Mobility
A Phase 1 study testing tsDCS Dosage (A), tsDCS Dosage (B) and textured shoe insoles in people with Aging, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- tsDCS Dosage (A), tsDCS Dosage (B) and textured shoe insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 18 Aug 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
About this study
Official title: Spinal Excitation to Enhance Mobility in Elderly Adults
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.
Read the 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.
- Conditions
- Aging
- Being tested
- tsDCS Dosage (A), tsDCS Dosage (B), textured shoe insoles
- Keywords
- aging, walking, spinal cord, electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tsDCS Dosage (A)Device
mild electrical stimulation delivered to lumbosacral spinal cord
tsDCS Dosage (B)Device
mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insolesOther
textured shoe insoles
| Study group | Role | What they receive |
|---|---|---|
| tsDCS Dosage A and textured insoles | Experimental | tsDCS dosage "A" and textured shoe insoles Receives: Device: tsDCS Dosage (A); Other: textured shoe insoles |
| tsDCS Dosage B and textured insoles | Experimental | tsDCS dosage "B" and textured shoe insoles Receives: Device: tsDCS Dosage (B); Other: textured shoe insoles |
| tsDCS Dosage A and smooth insoles | Experimental | tsDCS dosage "A" and smooth shoe insoles Receives: Device: tsDCS Dosage (A) |
| tsDCS Dosage B and smooth insoles | Experimental | tsDCS dosage "B" and smooth shoe insoles Receives: Device: tsDCS Dosage (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at session 2 (2 days after the baseline session)
Secondary outcomes (1)
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: Measured at session 2 (2 days after the baseline session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start17 Dec 2018
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of four different parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David J. Clark, DSc, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667573
- Sponsor's protocol ID
- E2874-P
- Other IDs
- I21RX002874
- Status last verified
- Aug 2023
- First submitted
- 6 Sep 2018
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35309891
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Excitation to Enhance Mobility in Elderly Adults
- ClinicalTrials.gov ID
- NCT03667573
- Acronym / sponsor ID
- E2874-P
- Conditions
- Aging
- Keywords
- aging, walking, spinal cord, electrical stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Posted 28 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants will be randomized to one of four different parallel groups
| Arm | Type | Receives |
|---|---|---|
| tsDCS Dosage A and textured insoles | Experimental | Device: tsDCS Dosage (A), Other: textured shoe insolestsDCS dosage "A" and textured shoe insoles |
| tsDCS Dosage B and textured insoles | Experimental | Device: tsDCS Dosage (B), Other: textured shoe insolestsDCS dosage "B" and textured shoe insoles |
| tsDCS Dosage A and smooth insoles | Experimental | Device: tsDCS Dosage (A)tsDCS dosage "A" and smooth shoe insoles |
| tsDCS Dosage B and smooth insoles | Experimental | Device: tsDCS Dosage (B)tsDCS dosage "B" and smooth shoe insoles |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (28 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tsDCS Dosage (A)mild electrical stimulation delivered to lumbosacral spinal cord | Device | tsDCS Dosage A and smooth insoles, tsDCS Dosage A and textured insoles |
| tsDCS Dosage (B)mild electrical stimulation delivered to lumbosacral spinal cord | Device | tsDCS Dosage B and smooth insoles, tsDCS Dosage B and textured insoles |
| textured shoe insolestextured shoe insoles | Other | tsDCS Dosage A and textured insoles, tsDCS Dosage B and textured insoles |
Primary outcome
Walking Speed Change From Baseline
Time frame: 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)
1 secondary outcome
Prefrontal fNIRS Change From Baseline
Time frame: Measured at session 2 (2 days after the baseline session)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35309891Clark 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J. Clark, DSc principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tsDCS Dosage (A), tsDCS Dosage (B) and textured shoe insoles in people with Aging, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed Change From Baseline (time frame: Measured at session 2 (2 days after the baseline session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03667573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.