Rehabilitation of Stroke Patients for Maximal Neurological Restoration

Stroke Clinical Trial

— PROTEQT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05086055
• Other study ID #: 171264
• Status: Recruiting
• Start date: November 11, 2021
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: Norwegian University of Science and Technology
• Contact: Axel Sandvig, PhD ass prof
• Phone: +46 72575620
• Email: axel.sandvig[@]ntnu.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Norway	OsloMet	Oslo
Norway	NextMove, NTNU	Trondheim
Norway	St Olavs Hospital Stroke Unit	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	OsloMet, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Changes in inflammatory activity in brain	Markers of post-stroke inflammation will be measured in pg/ml and ng/ml.	6 months
Primary	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