Rehabilitation of Stroke Patients for Maximal Neurological Restoration

Recruiting

• Conditions: Stroke
• Interventions: Behavioral: Kinematic movement analysis

• Registration Number: NCT05086055
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-20
• Study Start: 2021-11-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients	Kinematic movement analysis	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.
healthy volunteers	Kinematic movement analysis	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.

Primary Outcome Measures

Name	Time	Method
Changes in inflammatory activity in brain	6 months	Markers of post-stroke inflammation will be measured in pg/ml and ng/ml.
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.
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).
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

Trial Locations

Locations (3)

OsloMet; 🇳🇴 Oslo, Norway

NextMove, NTNU; 🇳🇴 Trondheim, Norway

St Olavs Hospital Stroke Unit; 🇳🇴 Trondheim, Norway