Status unknownNot a drug-phase studyEarly (CIS/RIS)NCT06179134

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Goal Management Training

What it measured

Main measures

  • Number of participants with improved Information processing speed

    5 weeks immediate post assessment, and 6 months post assessment

    Thinking and memory

Other measures (2)

  • Number of participants with improved learning and memory

    5 weeks immediate post assessment, and 6 months post assessment

    Thinking and memory
  • Number of participants with improved executive function

    5 weeks immediate post assessment, and 6 months post assessment

    Thinking and memory

Who could take part

Early (CIS/RIS) · 25 to 65

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jun 2024

    2. Main results due

      Dec 2024

    3. Finished

      Jan 2025

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