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NCT06179134
Cognitive Rehabilitation for People With Multiple Sclerosis
NA trial testing Goal Management Training in Multiple Sclerosis in 50 participants. Not yet recruiting.
31 December 2024
Quick facts
| Lead sponsor | Sunnybrook Health Sciences Centre |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 3 June 2024 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 January 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Goal Management Training
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
Sunnybrook Health Sciences Centre — full company profile →
Who can join
Adults 25 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06179134
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Related trials
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Trials testing the same drug.
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- NCT04076839 — The Effectiveness of a Cognitive Training Program, Goal Management Training, on Reducing Cognitive Difficulties and Impr · NA · completed
Other recruiting trials for Multiple Sclerosis
Currently open trials in the same condition.
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- NCT07236684 — Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity · recruiting
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Other Sunnybrook Health Sciences Centre trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06179134 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sunnybrook Health Sciences Centre
- Last refreshed: 16 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06179134.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing