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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

Tracking Information
First Submitted Date May 25, 2021
First Posted Date October 20, 2021
Last Update Posted Date November 19, 2021
Actual Study Start Date November 11, 2021
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2021)
  • 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.
  • 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).
  • Changes in inflammatory activity in brain [ Time Frame: 6 months ]
    Markers of post-stroke inflammation will be measured in pg/ml and ng/ml.
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rehabilitation of Stroke Patients for Maximal Neurological Restoration
Official Title Training the Surviving Neural Network to Create New Synaptic Connections That Can Maximize Restoration of Motor Functions After Stroke
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition 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.
Study Groups/Cohorts
  • 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.
    Intervention: Behavioral: Kinematic movement analysis
  • 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.
    Intervention: Behavioral: Kinematic movement analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 18, 2021)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Axel Sandvig, PhD ass prof +46 72575620 axel.sandvig@ntnu.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT05086055
Other Study ID Numbers 171264
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Norwegian University of Science and Technology
Study 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
PRS Account Norwegian University of Science and Technology
Verification Date November 2021