Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis (StraDiMS)

This study is a randomized controlled study in which we aim to include 60 persons with Multiple Sclerosis and 30 healthy controls. Two different learning strategies, an explicit and an implicit one, will be compared on effects on dual task performance. Further, clinical profile associated with these effects, and brain activity measured by functional near-infrared spectroscopy during dual tasking will be investigated.

To this end, the study will cover 4 days:

Day 1: examine clinical profile; Day 2: baseline dual task measures; Day 3: experimental learning paradigm with subjects randomly assigned to either the implicit or the explicit learning condition.

Day 4: delayed retention dual task and fNIRS measures.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: StraDiMS implicit; Behavioral: StraDiMs explicit

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Overpelt, Belgium, 3900
    • Noorderhart
  • Steenokkerzeel, Belgium, 1820
    • National MS Center Melsbroek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all participants: minimal cognitive function (MoCA ≥ 26)

• Persons with MS:

  • Diagnosis of MS
  • EDSS 2.0 - 5.5
  • No relapse within the past 30 days.
  • Able to walk minimally 6 minutes consecutively and to step over the stepping platform without aid.

Exclusion Criteria:

• Other medical conditions interfering with mobility.
• Other neurological conditions.
• Not able to understand instructions.
• Major (unresolvable) problems with hearing or vision.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MS group implicit	Behavioral: StraDiMS implicit; participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
EXPERIMENTAL: MS group explicit	Behavioral: StraDiMs explicit; participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
ACTIVE_COMPARATOR: HC group implicit (Healthy Controls)	Behavioral: StraDiMS implicit; participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
ACTIVE_COMPARATOR: HC group explicit (Healthy controls)	Behavioral: StraDiMs explicit; participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dual task (STEP + substraction sevens)	participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).	day 2
Dual task (STEP + substraction sevens)	participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task depends on the speed of the participant (42 steps).	day 4
Dual task (STEP + phonetic word list generation)	participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).	day 2
Dual task (STEP + phonetic word list generation)	participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task depends on the speed of the participant (42 steps).	day 4
Dual task (STEP + Auditory vigilance)	participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).	day 2
Dual task (STEP + Auditory vigilance)	participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task depends on the speed of the participant (42 steps).	day 4
Dual Task (WALK + Subtraction sevens)	participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.	day 2
Dual Task (WALK + Subtraction sevens)	participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they continuously subtract sevens, starting from a 3-digit given start number. Duration of the task is 30 seconds.	day 4
Dual Task (WALK + Word list generation (phonetic)	participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.	day 2
Dual Task (WALK + Word list generation (phonetic)	participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they try to come up with as many words as possible starting with a given letter. Duration of the task is 30 seconds.	day 4
Dual Task (WALK + Auditory vigilance)	participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.	day 2
Dual Task (WALK + Auditory vigilance)	participants will walk on their comfortable, preferred walking speed on a 30-meter walkway. Concurrently, they will perform a cognitive task in which they hear a string of letters (1 every 2.5 seconds) and are asked to respond as quickly as possible when they hear the target letter 'L' or 'R'. Duration of the task is 30 seconds.	day 4
learning measure	participants will step as fast as possible on a tile that lights up in a goal-directed stepping task on a platform consisting of 21 stepping tiles. The outcome measure on this task is response time (time from the moment the tile lights up, until the participant steps on the tile).	Day 3
fNIRS measure (functional near-infrared spectroscopy)	a block-design test with 3 tasks (cognitive ST, motor ST and DT) of 25 seconds per task-block (repeated 5 times) will be conducted with a functional near-infrared spectroscopy (fNIRS) neuroimaging system to measure hemoglobin changes during performance of the task and compared between single task and dual task conditions and between groups. Besides, fNIRS will be used during 1 task related to the learning-paradigm.	day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight		day 1
Age		day 1
height		day 1
educational level questionnaire		day 1
date of diagnosis questionnaire		day 1
type of MS questionnaire		day 1
EDSS	Expanded Disability Status Scale (EDSS)	day 1
Digit span forwards visually		day 1
Brief Visuospatial Memory Test (BVMT)		day 1
10/36 Spatial Recall test (SPART)		day 1
Symbol Digit Modalities Test (SDMT)		day 1
Paced Auditory Serial Addition Test (PASAT)-3 seconds		day 1
Digit Span backwards auditory		day 1
6 minute walking test (6MWT)		day 1
Timed-Up and Go (TUG)		day 1
Timed 25 Foot Walk (T25FW)		day 1
4 square stepping test (FSST)		day 1
Berg Balance Scale (BBS)		day 1
Tandem Walk 3m		day 1
Motricity Index		day 1
Movement specific reinvestment scale (MSRS)		day 1
MS Neuropsychological screening questionnaire (MSNQ)		day 1
Multiple Sclerosis Walking Scale (MSWS-12)		day 1
Modified fatigue impact scale (MFIS)		day 1
Activities-specific Balance Confidence scale (ABC)		day 1
Dual Task Questionnaire (DTQ)		day 1

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Revalidatie & MS Centrum Overpelt; National MS Center Melsbroek

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (ACTUAL): September 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: StraDiMS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No