Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis

NCT04538872 | Completed

• 1 other identifier: StraDiMS-001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (26)

• Age

  day 1

• height

  day 1

• weight

  day 1

• educational level questionnaire

  day 1

• date of diagnosis questionnaire

  day 1

Study Arms (4)

MS group implicit

EXPERIMENTAL

Behavioral: StraDiMS implicit

MS group explicit

EXPERIMENTAL

Behavioral: StraDiMs explicit

HC group implicit (Healthy Controls)

ACTIVE COMPARATOR

Behavioral: StraDiMS implicit

HC group explicit (Healthy controls)

ACTIVE COMPARATOR

Behavioral: StraDiMs explicit

Interventions

StraDiMS implicit BEHAVIORAL

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.

HC group implicit (Healthy Controls); MS group implicit

StraDiMs explicit BEHAVIORAL

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.

HC group explicit (Healthy controls); MS group explicit

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead
• National MS Center Melsbroek: collaborator
• Revalidatie & MS Centrum Overpelt: collaborator

Study Sites (2)

Noorderhart

Overpelt, 3900, Belgium

Location

National MS Center Melsbroek

Steenokkerzeel, 1820, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Feys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Renee Veldkamp, drs.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 4, 2020
• Study Start: September 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

BE (2)