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NCT06825598Enrolling by invitation

Neuroarchitectural Recovery Model of Post-stroke Patients

Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The societal burden of stroke patients with persistent neurological deficit is high. It is therefore imperative that the mechanisms of rehabilitation-induced motor recovery be better understood in the hopes of developing more efficacious rehabilitative therapy. The treatment outcomes of people with stroke after rehabilitation vary, with up to 60% of people having residual impairment of the upper limb function. The high variability in rehabilitation-induced recovery prompted researchers and clinicians to develop more efficacious rehabilitative interventions for functional regain in post-stroke patients. However, the mechanisms underlying post-stroke functional regain have not been well articulated. The majority of studies in this area placed a limited scope on associating improvement in functions with changes in the activation of the motor cortices, ranging from normalization to the overactivity of the motor regions. A wider scope, however, needs to include structural changes in the motor cortices, as well as functional and structural changes in other neural substrates, as other non-motor cortices underpin stroke recovery. The results of our pilot study on acute post-stroke patients indicate that both functional and structural brain connections are significantly associated with motor recovery after conventional post-stroke rehabilitation. In addition to sensorimotor cortices, the investigators also found other non-motor areas, such as the superior frontal gyrus and the precuneus, that play important roles in post-stroke rehabilitation-induced recovery. Given the gap in elusive neural processes and in the mechanisms underlying rehabilitation-induced recovery, this proposed study is aimed at providing a better understanding of the functional regain of post-stroke patients by constructing a brain recovery model. As a first attempt, the investigators propose building a basic recovery model based on patients who will undergo constraint-induced movement therapy, a popular evidence-based post-stroke intervention, for capturing training-induced neuroplastic changes. Two groups of chronic stroke patients will be recruited, respectively, for the treatment and control groups. Magnetic resonance imaging (used to map functional and structural brain connections), the clinical assessments of motor impairments, and activities of daily living will be conducted at four time points-namely at the baseline, one week, four weeks, and three months after the treatment commences. The two objectives set for the proposed study are: (1) to characterize the longitudinal changes in functional and structural brain networks, which would differentiate the rate of changes in these networks; and (2) to define the functional and the structural brain network coupling, as well as their contributions to the daily function regain.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
100 (estimated)
First submitted
10 Feb 2025
Start date
1 Dec 2024
Primary completion date
Dec 2026
Lead sponsor
Chinese University of Hong Kong
Diseases
Stroke
NCT number
NCT06825598

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Dec 2024 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with voluntary extension ≤ 10° in the metacarpophalangeal or interphalangeal joints, or ≤ 20° in the wrist; severe balance or walking disorders as indicated by the need for assistance in any activities of daily living; significant cognitive decline (score \<16) measured with the The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA);56 or a history of prior stroke, brain neoplasm, intracranial hemorrhages, transient ischemic attacks, diffusion abnormalities due to nonvascular etiology (for example, posterior reversible encephalopathy syndrome or global hypoxic ischemic encephalopathy), or other neurological/psychiatric or medical conditions that preclude active participation in research and/or may alter the interpretation of the behavioral/imaging studies (e.g., dementia, schizophrenia)

Who the study is looking for

  • Chronic post-stroke patients between 50 and 80 years old, and with the first-time ischemic stroke occurring three months or more after onset will be recruited to participate in the study. The reason for choosing chronic post-stroke patients is to minimize the effect of spontaneous recovery,55 which may confound the treatment-induced recovery. The recruited patients should present with motor deficits in the upper and/or lower extremities due to the stroke as measured using the Fugl-Meyer Motor Scale

Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The Polytechnic University of Hong Kong
Coordinator of this site? Confirm its status
Hung HomHong KongUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.