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

Catholic University (KU) of Leuven

Status: Unknown

Conditions: Multiple Sclerosis; Fatigue; Stress

Treatments: Behavioral: High-challenging cognitive protocol to provoke stress and (cognitive) fatigue

Study type: Observational

Funder types: Other

Identifiers

NCT05003375

S63552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diagnosis MS, Relapsing Remitting (RR) type (MS group)
• Expanded Disability Status Scale (EDSS) <6 (MS group)
• Dutch speaking
• normal or corrected vision
• feasible use of computer

Exclusion criteria

• relapse < 3 months (MS group)
• pregnancy
• relevant comorbidity (thyroid disease, diabetes, other neurological disorders, metabolic diseases, neuro-endocrine tumor(s)
• severe cognitive disability

Trial design

40 participants in 2 patient groups

Multiple Sclerosis (MS)

Description:

People with MS diagnosis, aged 18-55 years, Relapsing Remitting type, EDSS \< 6.0, normal vision (if necessary corrected), Dutch speaking.

Treatment:

Behavioral: High-challenging cognitive protocol to provoke stress and (cognitive) fatigue

Healthy Controls (HC)

Description:

Healthy controls without relevant health conditions (diabetes, thyroid diseases, neurological disorders), non-pregnant, aged 18-55 years, normal vision (if necessary corrected), Dutch speaking.

Treatment:

Behavioral: High-challenging cognitive protocol to provoke stress and (cognitive) fatigue