Clinical trial NCT05086055: Rehabilitation of Stroke Patients for Maximal Neurological Restoration
Official title: Training the Surviving Neural Network to Create New Synaptic Connections That Can Maximize Restoration of Motor Functions After Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Rehabilitation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: OsloMet
First posted: 2021-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18-years or older of both sexes with subcortical strokes resulting in arm motor deficit, admitted to the stroke unit, St Olav´s Hospital during 2020-2023. All patients admitted to the stroke unit will be scored according to National Institute of Health Score Scale (NIHSS) and the modified Rankin score (mRS) to establish the baseline clinical assessment of neurological dysfunction prior to inclusion

Brief summary: Multimodal imaging of stroke patients. Patients included in the study will be investigated with multiparametric imaging tools including MRI and EEG imaging. Improvements in motor skills will be monitored clinically.

Detailed description: We aim to (i) quantify the size of the brain lesion and assess the surviving functional neural network connections; (ii) Analyze the type and degree of inflammation initiated by the stroke-induced brain lesion. We will stratify inflammation according to lesion volume, surviving functional neural network connections, age, NIHSS and Modified Rankin Scale (mRS) and analyze how inflammation markers change during rehabilitation; (iii) Train the surviving neural network to create new synaptic connections that can maximize restoration of motor functions; (iv) Apply and develop advanced mathematical and computational methods to model and predict how stroke rehabilitation can rewire the neural network connections to best facilitate restoration of lost motor function.

Eligibility criteria: Inclusion Criteria:

* subcortical strokes resulting in arm motor deficits.
* admitted to the stroke unit, St Olav´s Hospital during 2021-2023

Exclusion Criteria:

* Previous stroke
* neurodegenerative disease
* brain tumors
* previous neurotrauma or brain operation
* aphasia
* cognitive dysfunction and claustrophobia preventing MRI examinations.

Primary outcomes:
measure: Changes in brain volume
timeFrame: 6 months
measure: Stroke induced changes in brain activity.
timeFrame: 6 months
measure: Changes in inflammatory activity in brain
timeFrame: 6 months
measure: muscle function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OsloMet
city: Trondheim
country: Norway
facility: NextMove, NTNU
city: Trondheim
country: Norway
facility: St Olavs Hospital Stroke Unit
Study officials:
affiliation: Norwegian University of Science and Technology
name: Axel Sandvig, PhD prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Jorunn Helbostad, PhD prof
role: STUDY_DIRECTOR
affiliation: St. Olavs Hospital
name: Bent Indredavik, PhD prof
role: STUDY_DIRECTOR
References: