PROTEQT: Rehabilitation of Stroke Patients for Maximal Neurological Restoration

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05086055
• Collaborator: St. Olavs Hospital (Other), OsloMet (Other)
• Enrollment: 200
• Locations: 3
• Anticipated Duration (Months): 26.7
• Patients Per Site: 66.7
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Training the Surviving Neural Network to Create New Synaptic Connections That Can Maximize Restoration of Motor Functions After Stroke
• Actual Study Start Date: Nov 11, 2021
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Changes in brain volume [6 months]

   Stroke induced brain volume changes (mm3) will be measured using magnetic resonance imaging (MRI) at 1 day and 6 months post-stroke.

2. Stroke induced changes in brain activity. [6 months]

   Document longitudinal changes in brain activity using EEG. Changes will be measured in cycles/second (Hertz, Hz).

3. Changes in inflammatory activity in brain [6 months]

   Markers of post-stroke inflammation will be measured in pg/ml and ng/ml.

4. muscle function [6 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OsloMet	Oslo		Norway
2	NextMove, NTNU	Trondheim		Norway
3	St Olavs Hospital Stroke Unit	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT05086055
• Other Study ID Numbers: 171264
• First Posted: Oct 20, 2021
• Last Update Posted: Nov 19, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Rehabilitation
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Nov 19, 2021