AzTrials
AzTrials

Multiple SclerosisNCT06179134

Cognitive Rehabilitation for People With Multiple Sclerosis

A study testing Goal Management Training in people with Multiple Sclerosis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Goal Management Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
3 Jun 2024to 31 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Anthony Feinstein

    Toronto, Ontario, M4Y 2P9

Other trials in Canada

About this study

Official title: Cognitive Rehabilitation Training for People With Multiple Sclerosis: a Randomized Controlled Trial

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.

Read more

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.

Read the detailed description

Background:

Multiple sclerosis (MS) is a chronic disabling disease of the central nervous system, with symptom onset commonly occurring between the ages of 20 to 40 years old; with females being at a higher risk of developing MS than men. Cognitive impairment (CI) in the last decade has been acknowledged as a prevalent core feature of the MS clinical picture, along with mobility issues. Cognitive impairment affects up to 44.5 % of people with relapsing remitting MS (RRMS), 79.4 % in secondary progressive MS (SP), and up to 91.3 % in people with primary progressive MS. The most prominent deficits reported being information processing speed, learning and memory and executive function. Cognitive decline has been found to directly affect the quality of life of people with MS, impacting participation in social activities, driving abilities, employment productivity, and task of daily living. Currently there is no approved medication for the treatment of CI in MS, patients and their clinicians are left with basically symptomatic treatments. In the last decade there has been an increase in developing non-pharmacological rehabilitation treatment to reverse or to at least slow down the progression of cognitive decline with cognitive rehabilitation.

KEYWORDS Learning and memory; executive function; information processing speed; Goal Management Training; multiple sclerosis.

Proposal and aims:

Cognitive rehabilitation (CR) is designed to enhance a person's capacity to process and interpret information and improve their ability to function in all aspects of family and community life. Given the clear and consistent documentation of cognitive deficits in persons with MS, there is an obvious need for effective cognitive rehabilitation. A leading cognitive rehabilitation program called Goal Management Training® (GMT), has been used as an effective treatment for a variety of patient populations, including traumatic brain injury, stroke, schizophrenia, attention deficit hyperactivity disorder and multiple sclerosis for the treatment of cognitive deficits specifically executive function, learning \& memory, and information processing speed.

A doctoral dissertation completed by Nadine Richards (2013), under the supervision of Brian Levine, investigated the effectiveness of the GMT intervention for multiple sclerosis (MS) patients with impaired cognition; using a double-blinded randomized controlled trial, with treatment group employing the GMT intervention and the sham group employing a psycho-educational intervention. Twenty eight participants were recruited, and randomized; participants in the GMT intervention learned stepwise strategies ("Stop-State-Split") to keep track of their daily activities, which included mindfulness training to enhance attentional awareness and control. The results post-training, revealed that compared to the psycho-educational control group, the GMT group was associated with greater improvement on test of executive-attentional processes as well as functional task performance and observable cognitive functioning in daily life activities, with effects remaining visible at 6 months. As of date this remains the only study carried out on patients with MS using the GMT intervention.

To elaborate further the GMT program, is a standardized metacognitive rehabilitation program designed to improve cognition. The GMT program contains 20 hours of training, that include employing the following tools psychoeducation, narrative examples mindfulness practice, and assignments completed both between and within sessions. The main objectives of the GMT intervention is to train individuals to periodically "STOP" what they are doing, attend to task goals, evaluate their performance, and monitor or check their performance as they proceed. The current version of GMT as mentioned above consists of 20 hours of training and its material and manual were made commercially available in 2012 by Baycrest Hospital (https://gmt.learnworlds.com/). The GMT cognitive rehabilitation training program is not considered a medical device and therefore not subject to Health Canada certification for use. As of April 20, 2023, the Goal Management program is now widely available through TELUS health's AbilitiCBT platform, and for clients across Canada and the United States (TELUS Health, 2023).

Given the devastating effects of cognitive impairment on social functioning, occupational functioning and everyday life activities in people with MS (pwMS), the amelioration of cognitive deficits is likely to improve everyday functioning in pwMS, thus greatly reducing the impact of the disease on the lives of people with MS and the overall cost of the disease to society at large. Therefore, efforts to improve cognitive abilities in this population may result in significant improvements in overall quality of life (QOL). The currently proposed study seeks to do just that.

The proposed pilot study will be a randomized controlled single-blinded trial with treatment and wait list control group. We aim to assess information processing speed, learning and memory, and executive function. The minimal assessment of cognitive function in MS (MACFIMS) will be utilized, to assess cognitive function. Additionally, the following 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 - 5 dimension - 5 level (EQ-5D-5L) scale, in order to capture level of, depression and anxiety, fatigue, impact of MS and quality of life. Patients in the cognitive rehabilitation group will be treated by GMT for 5 weeks (2 hour sessions, twice per week). The wait list control group will be given usual care/ routine care which consist of being provided with a list of cognitive compensatory strategies to do on their own. 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 control group, the participants receiving the Goal Management Training would demonstrate significant improvements across all cognitive measures.

Being tested
Goal Management Training
Keywords
Cognitive rehabilitation, Goal Management Training
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goal Management TrainingBehavioural

    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).

Study groups in NCT06179134
Study groupRoleWhat they receive
cognitive rehabilitation groupExperimentalwill be treated by GMT for 5 weeks (two hour sessions per week, one day of rest in between).
Receives: Behavioral: Goal Management Training
wait-list control groupNo interventionwill be given a list cognitive compensatory strategies that they can do on their own to improve their memory.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 weeks immediate post assessment, and 6 months post assessment

Secondary outcomes (2)
  1. Number of participants with improved learning and memory

    The California verbal learning test - 11 (CVLT-II) will be use to measure learning and memory.

    The CVLT-II is used to assess recall and recognition of items in a list of 16 nouns that belong to four categories (furniture, vehicles/ways of travelling, vegetables, and animals). the total raw score is the sum of correct responses on the five presentations. Higher scores means a better outcome.

    Measured: 5 weeks immediate post assessment, and 6 months post assessment

  2. Number of participants with improved executive function

    The Brief visuospatial memory test - revised (BVMT-R) will be use to measure executive function.

    Recall performance is recorded for each of the immediate recall trials (Trial 1, Trail 2, and Trial 3) and for the delayed recall trial (Delayed Recall).The recall scores are combined to form three additional summary measures of executive memory. Higher scores means a better outcome.

    Measured: 5 weeks immediate post assessment, and 6 months post assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2023
  2. Study start3 Jun 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized controlled single-blinded trial with treatment and wait list control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06179134
Sponsor's protocol ID
23-170
Status last verified
Apr 2024
First submitted
29 Nov 2023
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data that support the findings of this study are available on request from the corresponding author, Dr. Anthony Feinstein. The data are not publicly available due to restrictions e.g. their containing information that could compromise the privacy of research participants.

Publications

  • 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.

    PubMed 29540124

Questions about this trial

What is this clinical trial studying?

A study testing Goal Management Training in people with Multiple Sclerosis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cecilia Meza, MA (416 480 6100 ext. 67626, cecilia.meza@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with improved Information processing speed (time frame: 5 weeks immediate post assessment, and 6 months post assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06179134, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in