Rehabilitation of Stroke Patients for Maximal Neurological Restoration (PROTEQT)

Training the Surviving Neural Network to Create New Synaptic Connections That Can Maximize Restoration of Motor Functions After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Kinematic movement analysis

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Axel Sandvig, PhD ass prof; Phone Number: +46 72575620; Email: axel.sandvig@ntnu.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • OsloMet
    • Contact: Peyman Mirtaheri, PhD
  • Trondheim, Norway
    • Recruiting
    • St Olavs Hospital Stroke Unit
    • Contact: Gitta Rohweder, PhD
  • Trondheim, Norway
    • Recruiting
    • NextMove, NTNU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in brain volume	Stroke induced brain volume changes (mm3) will be measured using magnetic resonance imaging (MRI) at 1 day and 6 months post-stroke.	6 months
Stroke induced changes in brain activity.	Document longitudinal changes in brain activity using EEG. Changes will be measured in cycles/second (Hertz, Hz).	6 months
Changes in inflammatory activity in brain	Markers of post-stroke inflammation will be measured in pg/ml and ng/ml.	6 months
muscle function	Longitudinal kinematic profiling. Electromyography measurements of muscle function post-stroke will be measured in cycles/second (Hz) and amplitude (mm). Extension and flexion of arm will be measured in cm. Joint angles will be measured in degrees. Speed of flexion and extension will be measured in cm/second	6 months

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; OsloMet
• Investigators: Principal Investigator: Axel Sandvig, PhD prof, Norwegian University of Science and Technology; Study Director: Jorunn Helbostad, PhD prof, Norwegian University of Science and Technology; Study Director: Bent Indredavik, PhD prof, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 171264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No