Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000925347p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
28/05/2026
Date registered
Help: Date registered
28/07/2026
Date last updated
Help: Date last updated
28/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Direct current stimulation on walking and movement in people with Multiple Sclerosis: an experimental study of immediate and carry-over effects
Scientific title
Neuroprosthetic and Therapeutic Effects of Direct Current Stimulation on Acute Functional Outcomes in Multiple Sclerosis: A Within-Subject Experimental Study’
Additional trial identifiers [1] 317424 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Multiple Sclerosis 342098 0
Condition category
Condition code
Neurological 338216 338216 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 334217 0
Treatment: Devices
Intervention code [2] 334218 0
Rehabilitation
Description of the comparator or control
No device — participants complete the same functional assessments without DC stimulation (baseline phase, T1, and post-washout T3). This within-subject design uses each participant as their own control. Participants act as their own control.

Description of Comparator or Control
The study uses a within-subject repeated-measures design comprising four sequential phases, with each participant serving as their own control:

Baseline (T0): Participants complete all functional outcome measures without DC stimulation at a separate baseline visit, conducted a minimum of 48 hours before the intervention visit, to establish true baseline functional performance.
Pre-intervention (T1): On the day of the intervention visit, functional measures are repeated immediately prior to the intervention session and without stimulation, to confirm stable baseline performance and account for test–retest variability. T1 serves as the within-day no-stimulation control condition.
Intervention (T2): Immediately following T1 and electrode placement/titration, participants complete all functional outcome measures while receiving Neubie pulsed DC stimulation (frequency 100–160 pps; intensity titrated to 7/10 verbal rating scale; 3 blocks of 12 minutes per body area; total active stimulation approximately 36 minutes). This is the primary active condition. The total session duration including titration and electrode placement is approximately 60 minutes.
Post-washout (T3): Immediately following T2, participants undergo a 30-minute seated washout period (device off, electrodes removed). They then repeat all functional outcome measures without stimulation to determine whether any observed effects persist beyond the stimulation period or return to baseline. The total T1–T3 visit duration is approximately 3–4 hours.
Control group
Active

Outcomes
Primary outcome [1] 345578 0
Functional mobility
Timepoint [1] 345578 0
T1 (pre-intervention, no device), T2 (during DC stimulation, immediately following T1), T3 (30 minutes post-T2, no device).
Primary outcome [2] 345583 0
Lower limb functional strength
Timepoint [2] 345583 0
T1 (pre-intervention, no device), T2 (during DC stimulation, immediately following T1), T3 (30 minutes post-T2, no device).
Secondary outcome [1] 462245 0
Lower Limb Strength
Timepoint [1] 462245 0
T1 (pre-intervention, no device), T2 (during DC stimulation, immediately following T1), T3 (30 minutes post-T2, no device).
Secondary outcome [2] 462246 0
Spasticity
Timepoint [2] 462246 0
T1 (pre-intervention, no device), T2 (during DC stimulation, immediately following T1), T3 (30 minutes post-T2, no device).
Secondary outcome [3] 462247 0
Active range of motion
Timepoint [3] 462247 0
T1 (pre-intervention, no device), T2 (during DC stimulation, immediately following T1), T3 (30 minutes post-T2, no device).
Secondary outcome [4] 462248 0
Patient reported spasticity
Timepoint [4] 462248 0
T1 (pre-intervention, no device), T2 (during DC stimulation, immediately following T1), T3 (30 minutes post-T2, no device).
Secondary outcome [5] 462250 0
Fatigue
Timepoint [5] 462250 0
T1 (pre-intervention, no device), T2 (during DC stimulation, immediately following T1), T3 (30 minutes post-T2, no device).
Secondary outcome [6] 462251 0
Device usability
Timepoint [6] 462251 0
T1 (pre-intervention, no device), T2 (during DC stimulation, immediately following T1), T3 (30 minutes post-T2, no device).
Secondary outcome [7] 462252 0
Comfort/tolerability
Timepoint [7] 462252 0
T1 (pre-intervention, no device), T2 (during DC stimulation, immediately following T1), T3 (30 minutes post-T2, no device).

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
1/03/2027
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 321999 0
University
Name [1] 321999 0
Australian Catholic University
Country [1] 321999 0
Australia
Funding source category [2] 322001 0
Commercial sector/Industry
Name [2] 322001 0
Apex Health Movement
Country [2] 322001 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 324874 0
Commercial sector/Industry
Name [1] 324874 0
Apex Health Movement
Address [1] 324874 0
Country [1] 324874 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320532 0
ACU Human Research Ethics Committee
Ethics committee address [1] 320532 0
Ethics committee country [1] 320532 0
Australia
Date submitted for ethics approval [1] 320532 0
08/05/2026
Approval date [1] 320532 0
Ethics approval number [1] 320532 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150778 0
Prof Michael Cole
Address 150778 0
1100 Nudgee Road, Banyo, QLD, 4014, Australian Catholic University.
Country 150778 0
Australia
Phone 150778 0
+61 7 3623 7674
Fax 150778 0
Email 150778 0
[email protected]
Contact person for public queries
Name 150779 0
Michael Cole
Address 150779 0
1100 Nudgee Road, Banyo, QLD, 4014, Australian Catholic University
Country 150779 0
Australia
Phone 150779 0
+61 7 3623 7674
Fax 150779 0
Email 150779 0
[email protected]
Contact person for scientific queries
Name 150780 0
Michael Cole
Address 150780 0
1100 Nudgee Road, Banyo, QLD, 4014, Australian Catholic University
Country 150780 0
Australia
Phone 150780 0
+61 7 3623 7674
Fax 150780 0
Email 150780 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    PICF_Study_2_Finalv1.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.