Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rehabilitation of Stroke Patients for Maximal Neurological Restoration (PROTEQT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05086055
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : November 19, 2021
Sponsor:
Collaborators:
St. Olavs Hospital
OsloMet
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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
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.

Layout table for study information
Study Type : Observational
Estimated 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 : November 11, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. Changes in brain volume [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 6 months ]
    Markers of post-stroke inflammation will be measured in pg/ml and ng/ml.

  4. muscle function [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086055


Contacts
Layout table for location contacts
Contact: Axel Sandvig, PhD ass prof +46 72575620 axel.sandvig@ntnu.no

Locations
Layout table for location information
Norway
OsloMet Recruiting
Oslo, Norway
Contact: Peyman Mirtaheri, PhD         
NextMove, NTNU Recruiting
Trondheim, Norway
St Olavs Hospital Stroke Unit Recruiting
Trondheim, Norway
Contact: Gitta Rohweder, PhD         
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
OsloMet
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT05086055    
Other Study ID Numbers: 171264
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases