Skip to content

Effect of Direct current stimulation on walking and movement in people with Multiple Sclerosis: an experimental study of immediate and carry-over effects

Neuroprosthetic and Therapeutic Effects of Direct Current Stimulation on Acute Functional Outcomes in Multiple Sclerosis: A Within-Subject Experimental Study’

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000925347
Enrollment
20
Registered
2026-07-28
Start date
2026-09-01
Completion date
2027-03-01
Last updated
2026-08-03

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

Conditions

None listed

Brief summary

People with Multiple Sclerosis (MS) commonly experience muscle weakness, spasticity, and impaired walking ability. This study investigates whether direct current (DC) electrical stimulation, delivered via the Neubie device to lower-limb muscles, can produce immediate improvements in walking, balance, and functional movement in people with MS. Using a within-subject repeated-baseline design, 20 adults with MS will undergo functional assessments without the device (baseline), during active DC stimulation, and again 30 minutes after the device is removed. This will allow us to determine whether any improvements reflect an immediate assistive (neuroprosthetic) effect or persist after the device is turned off (a therapeutic effect). Participants will also rate their comfort and perception of the device. Results will inform whether DC stimulation is a viable rehabilitation tool for improving movement in MS.

Interventions

Intervention (Neubie DC Stimulation) Pulsed direct current (DC) stimulation will be delivered via the Neubie (Neuro-Bio-Electric Stimulator), applied bilaterally to the tibialis anterior, gastrocnemius, quadriceps (rectus femoris and vastus medialis), and hamstrings. The single intervention session will last approximately 60 minutes in total. Stimulation will be individualised to each participant's tolerance. Frequency will be set at 100–160 pps, consistent with the neuromuscular re-education ap

Intervention (Neubie DC Stimulation) Pulsed direct current (DC) stimulation will be delivered via the Neubie (Neuro-Bio-Electric Stimulator), applied bilaterally to the tibialis anterior, gastrocnemius, quadriceps (rectus femoris and vastus medialis), and hamstrings. The single intervention session will last approximately 60 minutes in total. Stimulation will be individualised to each participant's tolerance. Frequency will be set at 100–160 pps, consistent with the neuromuscular re-education application of the device. In accordance with NeuFit device guidelines, stimulation at this frequency range is limited to a maximum of 12 minutes per body area; stimulation will therefore be structured as 3 blocks of 12 minutes, each targeting a different lower-limb muscle group (Block 1: tibialis anterior and gastrocnemius; Block 2: quadriceps; Block 3: hamstrings), giving a total active stimulation time of approximately 36 minutes. As the Neubie delivers a proprietary pulsed DC waveform, pulse width is not an independently adjustable parameter — it is determined by the device's fixed internal waveform architecture and the selected frequency setting, and therefore no conventional pulse width range (e.g., in µs) can be specified. Similarly, intensity is not expressed in mA on this device; it is titrated individually using the NeuFit six-level power scale, targeting Level 3 (First Contraction) to Level 5 (Uncomfortable and Challenging), with intensity increased incrementally until each participant reaches a subjective intensity of 7/10 on a verbal rating scale. Intensity will not exceed a VAS-Pain ceiling of =4/10. The Neubie does not have an automated ramp function; intensity is manually titrated by incremental dial increases with verbal rating checks at each step. Stimulation will be delivered continuously within each 12-minute block, with brief pauses between blocks for electrode repositioning to the next muscle group. Functional assessments completed during stimulation include the Five Times Sit-to-Stand Test (5×STS), Timed Up and Go (TUG), 10-Metre Walk Test (10MWT), 2-Minute Walk Test (2MWT), handheld dynamometry, distributed across the three stimulation blocks according to the muscle groups being targeted. Stimulation will be administered by a trained researcher in a face-to-face clinical/laboratory setting.

Sponsors

Australian Catholic University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Confirmed diagnosis of multiple sclerosis EDSS score of equal to or below 6.0 Ability to walk independently or with single-point assistance Stable disease course with no relapse in the preceding three months No contraindications to electrical stimulation

Exclusion criteria

EDSS score >6.0 Relapse within the preceding three months Contraindications to electrical stimulation Unable to walk independently or with single-point assistance

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 10, 2026