StrokePROTEQTNCT05086055
Rehabilitation of Stroke Patients for Maximal Neurological Restoration
An observational study of Stroke, run by Norwegian University of Science and Technology at 3 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Kinematic movement analysis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 3 sitesNorway
- Study dates
- 11 Nov 2021to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- subcortical strokes resulting in arm motor deficits.
- admitted to the stroke unit, St Olav´s Hospital during 2021-2023
Who cannot join
- Previous stroke
- neurodegenerative disease
- brain tumors
- previous neurotrauma or brain operation
- aphasia
- cognitive dysfunction and claustrophobia preventing MRI examinations.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites, 3 recruiting
- Recruiting
OsloMet
Oslo
Peyman Mirtaheri, PhD
- Recruiting
NextMove, NTNU
Trondheim
- Recruiting
St Olavs Hospital Stroke Unit
Trondheim
Gitta Rohweder, PhD
About this study
Official title: Training the Surviving Neural Network to Create New Synaptic Connections That Can Maximize Restoration of Motor Functions After Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Kinematic movement analysis
- Keywords
- Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinematic movement analysisBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Kinematic movement analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Stroke induced changes in brain activity.
Document longitudinal changes in brain activity using EEG. Changes will be measured in cycles/second (Hertz, Hz).
Measured: 6 months
Changes in inflammatory activity in brain
Markers of post-stroke inflammation will be measured in pg/ml and ng/ml.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start11 Nov 2021
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, OsloMet
- Responsible party
- Sponsor
- Investigators
- Axel Sandvig, PhD prof, Principal investigator, Norwegian University of Science and TechnologyJorunn Helbostad, PhD prof, Study director, Norwegian University of Science and TechnologyBent Indredavik, PhD prof, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086055
- Sponsor's protocol ID
- 171264
- Acronym
- PROTEQT
- Status last verified
- Nov 2023
- First submitted
- 25 May 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avci-Colak E, Rohweder G, Iandolo R, Bommarito G, Sandvig I, Sandvig A. Structural connectome changes as biomarkers of stroke recovery: a longitudinal 7T MRI study. BMC Neurosci. 2026 May 14;27(1):19. doi: 10.1186/s12868-026-01010-9.
PubMed 42135684
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training the Surviving Neural Network to Create New Synaptic Connections That Can Maximize Restoration of Motor Functions After Stroke
- ClinicalTrials.gov ID
- NCT05086055
- Acronym / sponsor ID
- PROTEQT / 171264
- Conditions
- Stroke
- Keywords
- Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, OsloMet
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Behavioral: Kinematic movement analysisStroke 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 | – | Behavioral: Kinematic movement analysisAge 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- subcortical strokes resulting in arm motor deficits.
- admitted to the stroke unit, St Olav´s Hospital during 2021-2023
Key exclusion criteria (6 listed)
- Previous stroke
- neurodegenerative disease
- brain tumors
- previous neurotrauma or brain operation
- aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinematic movement analysismoving arm/leg while registration with electromyography, electroencephalogram, accelerometers, functional near infrared spectroscopy and 3 dimensional video registration of hand, arm, foot and leg movements. | Behavioural | Stroke patients, healthy volunteers |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 42135684Avci-Colak E, Rohweder G, Iandolo R, Bommarito G, Sandvig I, Sandvig A. Structural connectome changes as biomarkers of stroke recovery: a longitudinal 7T MRI study. BMC Neurosci. 2026 May 14;27(1):19. doi: 10.1186/s12868-026-01010-9.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Sandvig, PhD prof principal investigator
Norwegian University of Science and Technology
Jorunn Helbostad, PhD prof study director
Norwegian University of Science and Technology
Bent Indredavik, PhD prof study director
St. Olavs Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Norwegian University of Science and Technology at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Axel Sandvig, PhD ass prof (+46 72575620, axel.sandvig@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain volume (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05086055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.