Neuromodulation in MS Using Translingual Stimulation

Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT

Status unknownNot a drug-phase studyMS (type not specified)NCT05275049

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • PT plus translingual stimulation device

Compared with

  • PT plus translingual stimulation control device

What it measured

Main measures

  • Timed 25 foot walk test (T25FWT)

    27 weeks

    Disability progressionWalking and mobility

  • Dynamic Gait Index (DGI)

    27 weeks

    Walking and mobility

Other measures (4)

  • Multiple Sclerosis Impact Scale (MSIS-29)

    27 weeks

    Quality of life (reported by participants)

  • Fatigue Scale for Motor and Cognitive Functions

    27 weeks

    Thinking and memoryFatigue

  • Short From 36 Health Survey Questionnaire (SF-36)

    27 weeks

    FatiguePainQuality of life (reported by participants)

  • Multiple sclerosis walking scale - 12 item (MSWS-12)

    27 weeks

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 70 · EDSS 3 to 6

Show the full criteria

Inclusion criteria

* confirmed diagnosis of multiple sclerosis * gait deficit due to MS but still able to walk (EDSS less than 6.5, PDDS 3-6) * older than 18 and less than 70 years of age * agree to the study time commitment.

Exclusion criteria

* currently attending physical rehabilitation for walking and/or balance training, * currently already functional community ambulators (gait speed>120cm/s) * contra-indications to the use of translingual electrical stimulation (active or suspected malignant tumor; recent bleeding or open wounds in mouth; women who are pregnant, or sensitivity to nickel, gold or copper)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The overarching aim of this study is to examine if there is additional benefit to adding trans-lingual electrical stimulation to physiotherapy aimed at improving walking and balance in people with multiple sclerosis (MS).

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History

    1. Started

      Jul 2021

    2. Main results due

      Jul 2022

    3. Finished

      Dec 2022

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