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TENS in Persons With MS

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Trancutaneous Electrical Nerve Stimulation
Strength training
Sham stimulation
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • EDSS score < 7
  • MSWS score > 30
  • FSS score > 4 or MFIS score > 38.
  • no known cardiovascular disorder or having a positive advice on a sport medical examination

Exclusion Criteria:

  • being a participant in an exercise study
  • having a psychiatric disorder
  • having cognitive or communication problems which reduces the capacity to understand instructions
  • planned a change in medication during the training period
  • having a neurological disorder other than MS
  • having cardiovascular disorders and no positive advice from a sport medical examination
  • having a pacemaker or another implantable electronic apparatus.
  • being pregnant

Sites / Locations

  • University Medical Centre GroningenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

Control group

Strength-training group

Trancutaneous Electrical Nerve Stimulation (TENS)

TENS with strength training

Arm Description

Sham stimulation will be applied over rectus femoris, tibialis anterior, the median nerve and the thenar eminence on both sides for 10 min to each limb, one at a time. Stimulation is delivered for 10 min to each limb, one at a time in three 10 minute sessions per week, for 4 weeks.

Three training sessions for 10 minutes per muscle per week, for 4 weeks during which sham stimulation will be applied.

Trancutaneous Electrical Nerve Stimulation (TENS) stimulation applied over rectus femoris, tibialis anterior, the median nerve and the thenar eminence on both sides for 10 min to each limb, one at a time. Stimulation is delivered for 10 min to each limb, one at a time in three 10 minute sessions per week, for 4 weeks.

Three training sessions for 10 minutes per muscle per week, for 4 weeks during which Trancutaneous Electrical Nerve Stimulation (TENS) stimulation is applied over rectus femoris, tibialis anterior, the median nerve and the thenar eminence on both sides for 10 min to each limb, one at a time.

Outcomes

Primary Outcome Measures

6-minute walk test
This test assesses submaximal aerobic capactity. Subjects walk for 6 minutes starting at mark on the floor at the beginning of a 30-m long hallway and walk to the next mark at the end of the hallway as quickly as possible, but safely. The distance which is walked by the subject is measured. Subjects may use assistive devices when performing the task.
chair-stand test
This test assesses functional lower extremity strength. Subjects sit on a chair and stand up repeatedly for 30 s. Arms of the subject are crossed and held against the chest. The number of cycles of standing up from sitting are counted.
Fatigue Severity Scale (FSS)
This is a questionnaire related to the impact of fatigue on daily life. The questionnaire consists of 9 questions with a 7-point scale ranging from 'completely agree' to 'completely disagree'. The total score ranges from 9 to 63; higher scores reflect a higher impact.
Modified Fatigue Impact Scale (MFIS)
This is a questionnaire related to sense of fatigue. The questionnaire consist of 21 questions providing assessment of the effect of fatigue in terms of physical, cognitive and psychosocial function. The total score ranges from 0 to 84; higher scores reflect a higher impact of fatigue.
12-item MS walking scale (MSWS-12)
This is a patient-base measure of walking ability. The questionnaire consists of 12 items with a 5-point scale ranging from 'not at all' to 'extremely'. The total score ranges from 5 to 60, with higher scores reflecting more walking difficulties.

Secondary Outcome Measures

Elbow flexor muscle force (maximal and submaximal levels)
Maximal voluntary force (MVC) of the elbow flexors is measured with a custom-built dynamometer. Subjects are seated in a chair with their arm abducted and in 90° of flexion with their non-dominant arm strapped to the force transducer. Subjects are instructed to contract their elbow flexors as rapidly and forcefully as possible and to maintain force generation for 5 s. MVC is determined as the peak force.
Knee extensor muscle force (maximal and submaximal levels)
Maximal voluntary force (MVC) of the knee extensors is measured with a custom-built dynamometer. Subjects are seated in a chair with the knee and hip in 90° of flexion with their non-dominant lower leg strapped to the chair's lever arm (~ 10 cm up to lateral malleolus). Subjects are instructed to contract their knee extensors as rapidly and forcefully as possible and to maintain force generation for 5 s. MVC is determined as the peak force.
Handgrip force
Maximal voluntary force (MVC) of the handgrip is measured with a hydraulic hand dynamometer (JAMAR Hand Dynamometer). The measurement is repeated 3 times and averaged.
Effort during submaximal contractions with elbow flexors
Subjects are asked to produce different submaximal force levels of the elbow flexors (20, 30, 50 and 70%) and rate their perceived effort (scale 1-10) that was needed to generate this force level.
Effort during submaximal contractions with knee extensors
Subjects are asked to produce different submaximal force levels of the knee extensors (20, 30, 50 and 70%) and rate their perceived effort (scale 1-10) that was needed to generate this force level.

Full Information

First Posted
April 1, 2022
Last Updated
March 6, 2023
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT05321927
Brief Title
TENS in Persons With MS
Official Title
Transcutaneous Electrical Nerve Stimulation in Persons With MS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Persons with multiple sclerosis (pwMS) often have an increased sense of fatigue. Furthermore, they present walking difficulties which negatively affects their mobility and results in an additional increase of fatigue. Previous literature suggests that transcutaneous electrical nerve stimulation (TENS) of leg muscles might increase their walking capacity and decrease perception of fatigue. In the present study we aim to investigate whether TENS of leg muscles reduces walking difficulties and sense of fatigue in pwMS in comparison with a short strength training protocol or no training. A similar aim is addressed after TENS of elbow flexor muscles. Subjects with relapsing remitting or progressive MS, age between 18 and 65 years, will undergo transcutaneous electrical nerve stimulation (TENS), strength exercises (SExerc), both TENS and SExerc (COMB) simultaneously, or sham stimulation without training (CON) of both leg and arm muscles. Force and fatigue measurements are performed before, directly after and three weeks after the training sessions and contain walking, fatigue, and strength assessments. Main study parameters are changes in the scores of i) the six-minute walking test (6-MWT), ii) the perceived walking disability (MSWS-12) and iii) fatigue questionnaires (FSS and MFIS). Additional study parameters are changes in muscle force and muscle fatigability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Sham stimulation will be applied over rectus femoris, tibialis anterior, the median nerve and the thenar eminence on both sides for 10 min to each limb, one at a time. Stimulation is delivered for 10 min to each limb, one at a time in three 10 minute sessions per week, for 4 weeks.
Arm Title
Strength-training group
Arm Type
Active Comparator
Arm Description
Three training sessions for 10 minutes per muscle per week, for 4 weeks during which sham stimulation will be applied.
Arm Title
Trancutaneous Electrical Nerve Stimulation (TENS)
Arm Type
Active Comparator
Arm Description
Trancutaneous Electrical Nerve Stimulation (TENS) stimulation applied over rectus femoris, tibialis anterior, the median nerve and the thenar eminence on both sides for 10 min to each limb, one at a time. Stimulation is delivered for 10 min to each limb, one at a time in three 10 minute sessions per week, for 4 weeks.
Arm Title
TENS with strength training
Arm Type
Experimental
Arm Description
Three training sessions for 10 minutes per muscle per week, for 4 weeks during which Trancutaneous Electrical Nerve Stimulation (TENS) stimulation is applied over rectus femoris, tibialis anterior, the median nerve and the thenar eminence on both sides for 10 min to each limb, one at a time.
Intervention Type
Device
Intervention Name(s)
Trancutaneous Electrical Nerve Stimulation
Other Intervention Name(s)
TENS
Intervention Description
Transcutaneous Electrical Nerve Stimulation produces an electrical current to stimulate the nerves for therapeutic purposes. continuous high frequency (≥ 50 Hz) stimulation for 5 minutes followed by high frequency (≥ 50 Hz) bursts with 9 pulses per burst for the last 5 minutes, with a stimulation/rest ratio of 1:2.
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
Three training sessions for 10 minutes per muscle, per week, for four weeks in total.
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
Continuous stimulation at 1 Hz for 2 seconds, then no stimulation for 10 seconds. This will alternate for 10 minutes. The intensity equals the intensity that is just felt by the individual.
Primary Outcome Measure Information:
Title
6-minute walk test
Description
This test assesses submaximal aerobic capactity. Subjects walk for 6 minutes starting at mark on the floor at the beginning of a 30-m long hallway and walk to the next mark at the end of the hallway as quickly as possible, but safely. The distance which is walked by the subject is measured. Subjects may use assistive devices when performing the task.
Time Frame
6 weeks
Title
chair-stand test
Description
This test assesses functional lower extremity strength. Subjects sit on a chair and stand up repeatedly for 30 s. Arms of the subject are crossed and held against the chest. The number of cycles of standing up from sitting are counted.
Time Frame
6 weeks
Title
Fatigue Severity Scale (FSS)
Description
This is a questionnaire related to the impact of fatigue on daily life. The questionnaire consists of 9 questions with a 7-point scale ranging from 'completely agree' to 'completely disagree'. The total score ranges from 9 to 63; higher scores reflect a higher impact.
Time Frame
6 weeks
Title
Modified Fatigue Impact Scale (MFIS)
Description
This is a questionnaire related to sense of fatigue. The questionnaire consist of 21 questions providing assessment of the effect of fatigue in terms of physical, cognitive and psychosocial function. The total score ranges from 0 to 84; higher scores reflect a higher impact of fatigue.
Time Frame
6 weeks
Title
12-item MS walking scale (MSWS-12)
Description
This is a patient-base measure of walking ability. The questionnaire consists of 12 items with a 5-point scale ranging from 'not at all' to 'extremely'. The total score ranges from 5 to 60, with higher scores reflecting more walking difficulties.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Elbow flexor muscle force (maximal and submaximal levels)
Description
Maximal voluntary force (MVC) of the elbow flexors is measured with a custom-built dynamometer. Subjects are seated in a chair with their arm abducted and in 90° of flexion with their non-dominant arm strapped to the force transducer. Subjects are instructed to contract their elbow flexors as rapidly and forcefully as possible and to maintain force generation for 5 s. MVC is determined as the peak force.
Time Frame
6 weeks
Title
Knee extensor muscle force (maximal and submaximal levels)
Description
Maximal voluntary force (MVC) of the knee extensors is measured with a custom-built dynamometer. Subjects are seated in a chair with the knee and hip in 90° of flexion with their non-dominant lower leg strapped to the chair's lever arm (~ 10 cm up to lateral malleolus). Subjects are instructed to contract their knee extensors as rapidly and forcefully as possible and to maintain force generation for 5 s. MVC is determined as the peak force.
Time Frame
6 weeks
Title
Handgrip force
Description
Maximal voluntary force (MVC) of the handgrip is measured with a hydraulic hand dynamometer (JAMAR Hand Dynamometer). The measurement is repeated 3 times and averaged.
Time Frame
6 weeks
Title
Effort during submaximal contractions with elbow flexors
Description
Subjects are asked to produce different submaximal force levels of the elbow flexors (20, 30, 50 and 70%) and rate their perceived effort (scale 1-10) that was needed to generate this force level.
Time Frame
6 weeks
Title
Effort during submaximal contractions with knee extensors
Description
Subjects are asked to produce different submaximal force levels of the knee extensors (20, 30, 50 and 70%) and rate their perceived effort (scale 1-10) that was needed to generate this force level.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Description
A self-report questionnaire with 54 items used to quantify health-related quality of life. Generates two separate composite scores for physical and mental health (0-100); higher scores indicate better quality of life.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: EDSS score < 7 MSWS score > 30 FSS score > 4 or MFIS score > 38. no known cardiovascular disorder or having a positive advice on a sport medical examination Exclusion Criteria: being a participant in an exercise study having a psychiatric disorder having cognitive or communication problems which reduces the capacity to understand instructions planned a change in medication during the training period having a neurological disorder other than MS having cardiovascular disorders and no positive advice from a sport medical examination having a pacemaker or another implantable electronic apparatus. being pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inge CAT Zijdewind, PhD
Phone
+31 50 361 6438
Email
c.a.t.zijdewind@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Nikki Dreijer, MSc
Email
n.dreijer@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge CAT Zijdewind, PhD
Organizational Affiliation
UMCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9713 AW
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inge CAT Zijdewind, PhD
Phone
+31 50 361 6438
Email
c.a.t.zijdewind@umcg.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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TENS in Persons With MS

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