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Rehabilitation of Stroke Patients for Maximal Neurological Restoration

NCT ID: NCT05086055

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-11

Study Completion Date

2024-02-29

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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Rehabilitation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Stroke patients

Stroke patients admitted to the stroke unit, St Olav´s hospital, Trondheim, Norway, without previous stroke, neurological disease or central nervous system (CNS) trauma, will be eligible for inclusion into the study. The planned cohort size is 135 patients.

Kinematic movement analysis

Intervention Type BEHAVIORAL

moving arm/leg while registration with electromyography, electroencephalogram, accelerometers, functional near infrared spectroscopy and 3 dimensional video registration of hand, arm, foot and leg movements.

healthy volunteers

Age and gender matched controls without previous CNS disease or trauma are eligible for inclusion into the study. Estimated cohort size is 45 individuals. Volunteers will be recruited through announcement in local newspaper.

Kinematic movement analysis

Intervention Type BEHAVIORAL

moving arm/leg while registration with electromyography, electroencephalogram, accelerometers, functional near infrared spectroscopy and 3 dimensional video registration of hand, arm, foot and leg movements.

Interventions

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Kinematic movement analysis

moving arm/leg while registration with electromyography, electroencephalogram, accelerometers, functional near infrared spectroscopy and 3 dimensional video registration of hand, arm, foot and leg movements.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

OsloMet

UNKNOWN

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Axel Sandvig, PhD prof

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Jorunn Helbostad, PhD prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Bent Indredavik, PhD prof

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

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OsloMet

Oslo, , Norway

Site Status RECRUITING

NextMove, NTNU

Trondheim, , Norway

Site Status RECRUITING

St Olavs Hospital Stroke Unit

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Axel Sandvig, PhD ass prof

Role: CONTACT

Phone: +46 72575620

Email: [email protected]

Facility Contacts

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Peyman Mirtaheri, PhD

Role: primary

Gitta Rohweder, PhD

Role: primary

Other Identifiers

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171264

Identifier Type: -

Identifier Source: org_study_id