NCT05003375

Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS)

Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS): a Feasibility Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The current study will add to the current knowledge by combining several electrophysiological techniques to examine the relationship between physiological responses and cognitive fatigue and daily activity performance in a stress- and fatigue-inducing protocol. The aims of this study are: 1) to evaluate the feasibility and usability of assessing physiological responses in an experimental set-up and 2) to investigate the association between physiological outcomes, experimentally induced stress and cognitive fatigue in people with multiple sclerosis (MS) and healthy controls.

Detailed description

In an experimental set-up participants (20 people with MS and 20 healthy controls) will perform a high-challenging cognitive protocol to provoke stress and (cognitive) fatigue. Physiological responses (heart rate variability, skin conductance, body temperature) and brain activity (EEG) will be measured while resting (resting baseline), while speaking as normal (speaking baseline), during protocol performance and following the protocol (post-protocol). Demographic and clinical characteristics, as well as levels of perceived fatigue, stress, pain, daily activity performance, quality of life and anxiety and depression will be assessed using medical records and questionnaires. Feasibility and usability will be assessed in participants and researcher(s) by standardized questionnaires.

Conditions

• Multiple Sclerosis
• Fatigue
• Stress

Interventions

Type	Name	Description
BEHAVIORAL	High-challenging cognitive protocol to provoke stress and (cognitive) fatigue	Baseline measurement is done in two parts: 1) resting for five minutes (no talking, no movement) and 2) speaking at normal pace (2 minutes). This is immediately followed by a measurement of the physiological response variables during the testing, in which the following protocol is performed in the order presented: 1) SDMT-NBack task-SDMT\*-NBacktask\*\*, 2) NBack task-SDMT-NBack task-SDMT. Participants will run either sequence to check for effects of the previous testing. During the conduct of the study, it will be ensured that half of the participants in each group followed Sequence 1 and the other half of the group followed Sequence 2. During all these measurements, the participant will sit at a table with a computer on which the tests are performed. \*SDMT: Symbol Digit Modalities Test: see description in outcome measures \*\*N-Back Task: see description in outcome measures

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-08-30
• Completion: 2021-09-01
• First posted: 2021-08-12
• Last updated: 2021-08-12

Locations

2 sites across 1 country: Belgium