Cognitive Rehabilitation for People With Multiple Sclerosis

NCT06179134 | Not Yet Recruiting

• 1 other identifier: 23-170
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive rehabilitation is designed to enhance a person's capacity to process and interpret information and improve their ability to function in all aspects daily, family and community life. Given the clear and consistent documentation of cognitive deficits in persons with MS, the most notable deficit being information processing speed, learning and memory and executive function, there is an obvious need for effective cognitive rehabilitation. The proposed study will be a randomized controlled single-blinded trial with treatment and wait-list control group. The treatment group will be administered the Goal Management Training (GMT) program; the wait-list control group will be given usual care by their neurologist. Intervention details: The treatment group will receive in-person computerized cognitive rehabilitation (using the GMT program) (virtual training is optional) for 5 weeks (40-min sessions, twice per week), session will be tailored according to patient cognitive concerns at index assessment, and level of ability. The wait list control group, will not receive treatment Our primary outcome is information processing speed, secondary aims include learning and memory, and executive function. The minimal assessment of cognitive function in MS (MACFIMS) will be utilized to assess cognitive function. Additionally, tertiary aims include the following patient reported outcomes (PROs) will be collected: the hospital anxiety and depression scale (HADS), the modified fatigue impact scale (MFIS), the multiple sclerosis impact scale (MSIS-29), and the European quality of life (EQ-5D-5L) scale, to capture level of depression and anxiety, fatigue, impact of MS and quality of life. Cognitive performance of all patients in both groups will be assessed at baseline, immediate post-5-week assessment, and at post 6-month follow-up assessment. We hypothesized that, compared to persons in the wait-list group, the participants receiving the GMT intervention will demonstrate significant improvements across all cognitive measures. The wait-list control group will be given the option to receive the GMT intervention after the 6 months follow-up is complete. The individuals in the treatment group, wishing to continue with the GMT program, will be given a referral by Dr. Feinstein to a GMT certified therapist.

Conditions

Multiple Sclerosis

Keywords

Cognitive rehabilitation; Goal Management Training

Outcome Measures

Primary Outcomes (1)

• Number of participants with improved Information processing speed

  The Symbol Digit Modality Test (SDMT), will be use to measure changes in processing speed. A poor SDMT score tells us that cognitive decline occurred. Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110). Higher scores means a better outcome.

  5 weeks immediate post assessment, and 6 months post assessment

Secondary Outcomes (2)

• Number of participants with improved learning and memory

  5 weeks immediate post assessment, and 6 months post assessment

• Number of participants with improved executive function

  5 weeks immediate post assessment, and 6 months post assessment

Other Outcomes (3)

• Number of people with improved fatigue symptoms

  5 weeks immediate post assessment, and 6 months post assessment

• Number of participants with improved anxiety symptoms

  5 weeks immediate post assessment, and 6 months post assessment

• Number of participants with improved depression symptoms

  5 weeks immediate post assessment, and 6 months post assessment

Study Arms (2)

cognitive rehabilitation group

EXPERIMENTAL

will be treated by GMT for 5 weeks (two hour sessions per week, one day of rest in between).

Behavioral: Goal Management Training

wait-list control group

NO INTERVENTION

will be given a list cognitive compensatory strategies that they can do on their own to improve their memory.

Interventions

Goal Management Training BEHAVIORAL

The main objective of GMT intervention are to train individuals to periodically "STOP "what they are doing, attend to task goals, evaluate their performance and monitor or check outcomes as they proceed (Levine \& Stamenova, 2017).

cognitive rehabilitation group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A define diagnosis of multiple sclerosis (which will include clinically isolate syndrome, radiologically isolated syndrome and neuromyelitis optica spectrum disorder).
• A performance below 1.5 or 2 standard deviations (SD) compared to the normative mean in at least 20-30% of the test parameters.
• Corrected near vision of 20/70 or better (to see test material)

You may not qualify if:

• Exclude persons with a history of central nervous system disease other than MS
• Use of illicit drugs, phencyclidine (PCP), Lysergic acid diethylamide (LSD), stimulants, amphetamines, barbiturates, etc. (Cannabis use is accepted)
• Psychotic symptoms, bipolar disorder, schizophrenia
• Exclude persons who have used steroids within the past 3 months
• Exclude persons unable or unwilling to travel to the Centre or requires transportation by ambulance.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Anthony Feinstein

Toronto, Ontario, M4Y 2P9, Canada

Location

Related Publications (1)

• Stamenova V, Levine B. Effectiveness of goal management training(R) in improving executive functions: A meta-analysis. Neuropsychol Rehabil. 2019 Dec;29(10):1569-1599. doi: 10.1080/09602011.2018.1438294. Epub 2018 Mar 14.

  PMID: 29540124 BACKGROUND

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

Central Study Contacts

Cecilia Meza, MA

CONTACT

416 480 6100; cecilia.meza@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead principal investigator

Model Details: This is a randomized controlled single-blinded trial with treatment and wait list control group.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 21, 2023
• Study Start: June 3, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)