NCT03667573

Spinal Excitation to Enhance Mobility

Completed Phase 1 Results posted Last updated 13 September 2023

What this trial tests

Phase 1 trial testing tsDCS Dosage (A) in Aging in 23 participants. Completed in 18 August 2021.

Timeline

17 December 2018

Primary endpoint
18 August 2021

18 August 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	23
Start date	17 December 2018
Primary completion	18 August 2021
Estimated completion	18 August 2021
Sites	1 location across United States

Drugs / interventions tested

• tsDCS Dosage (A)
• tsDCS Dosage (B)
• textured shoe insoles

Conditions studied

• Aging — all drugs for Aging →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

65 and older, any sex, with Aging. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Walking Speed Change From Baseline Primary · 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)

Group	Value	95% CI
tsDCS Dosage A and Textured Insoles	.054	± .054
tsDCS Dosage B and Textured Insoles	.078	± .04
tsDCS Dosage A and Smooth Insoles	.085	± .04
tsDCS Dosage B and Smooth Insoles	.039	± .12

Prefrontal fNIRS Change From Baseline Secondary · 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)

Group	Value	95% CI
tsDCS Dosage A and Textured Insoles	-1.21	± 0.93
tsDCS Dosage B and Textured Insoles	0.24	± 1.15
tsDCS Dosage A and Smooth Insoles	0.14	± 0.47
tsDCS Dosage B and Smooth Insoles	0.17	± 0.62

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enhancing Locomotor Learning With Transcutaneous Spinal Electrical Stimulation and Somatosensory Augmentation: A Pilot Randomized Controlled Trial in Older Adults.
   Clark DJ, Hawkins KA, Winesett SP, Cox BA, et al · · 2022 · cited 3× · PMID 35309891 · DOI 10.3389/fnagi.2022.837467