Regional AnaesthesiaNCT03965338
Assessment of Brain Activity During Complex Fine Hand Movements: an fMRI Study
An observational study of Regional Anaesthesia and Functional Magnetic Resonance Imaging, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Brain cortex controls movement but the influence of peripheral component of movement on the cortex is not known. Functional Magnetic Resonance Imaging(fMRI) studies in stroke and fantom limb patients investigate cortex areas activated during execution and imagination of complex hand movements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anaesthesia, Functional Magnetic Resonance Imaging
- What is being tested?
- fMRI
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 12 Apr 2020
- 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 scheduled to have right-hand surgery with peripheral blockage of the arm
Who may be able to join
- >18 years
- have right-hand surgery with peripheral blockage of the arm
- who give written informed consent
- who are right-hand dominant Exclusion criteria: Patients
- who do not give written informed consents,
- use their left hand dominantly,
Show all 15Show fewer
- have a neurologic or psychiatric disease,
- have hearing and visual loss,
- have a history of substance abuse
- have surgery in the previous 12 months,
- have major systemic disease(ASA III and IV),
- have history of drugs that alter neurologic activity,
- are unable to stay at MR machine without sedation,
- with an expected surgery duration of more than 3 hours,
- have a motor deficit at their right hand that makes the performance of the motor task impossible
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Brain cortex controls movement but the influence of peripheral component of movement on the cortex is not known. Functional Magnetic Resonance Imaging(fMRI) studies in stroke and fantom limb patients investigate cortex areas activated during execution and imagination of complex hand movements. These studies aim to understand the mechanisms of the motor component of movement but the results are limited as there is no effector organ in fantom limb patients and the affecting organ is damaged in stroke patients. The investigators hypothesized that the areas of the cortex that is activated to remember, set-up and order to move can be isolated from the areas that are activated during the motor component of movement. To prove this hypothesis the investigators developed a model that investigate the brain activation areas during the patient try to execute and imagine doing a complex motor task (sequential opposition with the thumb to the other four fingers) with a peripherally blocked arm. Brain fMRI in 15 right-handed patients scheduled to undergo right-hand surgery with peripheral block anesthesia will be obtained before the surgery day and just before surgery after the block. Participants will be screened when executing the task (after the block they just attempt), during rest and during they imagine doing the task. Bilateral cortex activation areas will be compared when the right hand was intact and was peripherally blocked.
There are many unknowns in the relationship between the brain-peripheric organ during movement. The investigators hope that some of these mechanisms will be identified by the new model we used in our study. The final benefit will be to develop stroke therapies and new therapies for neuropathic pain which is closely related to motor function.
Read the detailed description
In this study, the investigators aim to separate the cortex areas that are activated during one remember, set-up and plan and start doing a motor task from the areas that are activated during performing the motor component. The investigators hypothesized that these areas can be identified by screening areas with fMRI when participants are asked to perform a complex motor task with a hand that is completely blocked. The hypothesis is based on the fact that in a participant with a peripherally blocked arm the central component of the movement will not be affected and the activation areas that remember and plan to do a motor task can be separated from the areas that are activated when the effector organ is doing the motor task, in other words, the motor component of the task.
the investigators also aim to show;
- If there is an ipsilateral cortex activity during a participant with a peripherally blocked arm try to execute a complex motor task. The investigators know that in centrally paralyzed hands there is ipsilateral activity and there is no argument if this is an adaptive response or it is present from the beginning of the motor paralysis due to the strength of the central event of the contralateral brain area.
- If there is a difference between activation areas of the cortex during the imaginary of complex hand movements with the intact and peripherally blocked arms.
Adult patients (>18) that have been scheduled to have right-hand surgery with peripheral blockage of the arm will be evaluated for the study. The patients will be informed about all the details and the consequences of the study and patients who give written informed consent will be included in the study. Local ethics committee approval is obtained in 05.12.2018. the study will be continued until the planned 15 patients are recruited for the study.
Right-hand dominance of the patient will be confirmed by Edinburgh handedness inventory (Oldfield,1971) and scores will be recorded. In the end, the mean of the score will be obtained for the whole study population. medium-high degree right handedness will be required for inclusion to the study. The patients who do not give written informed consents, patients who use their left hand dominantly, patients who have a neurologic or psychiatric disease, the patients with hearing and visual loss, who have history of substance abuse or who had surgery in the previous 12 months, with a history of major systemic disease (ASA III and IV) , with history of drugs that alter neurologic activity, who are unable to stay at MR machine without sedation, who are accepted to have a surgery duration of more than 3 hours, and patients who have a motor deficit at their right hand that makes the performance of the motor task impossible will not be included to the study. before the MR scanning patients will have a neurologic examination to show any neurologic insult related to the pathology they will have the operation for.
All these examinations and evaluations will be made at most 10 days before surgery.
The participants will perform a given motor task of block sequence. Patients will touch the other digits by the thumb in a given order and sequence. At the same session patients, will be screened while imagining doing the same task. The orders to rest, imagine and perform the task will be given by an MRI compatible monitor- mirror set. Patients will practice the task of the experiment before the real screening sessions. The patients will be observed while in the magnet to see if they perform the task appropriately.
- Being tested
- fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDiagnostic test
Screening
| Study group | Role | What they receive |
|---|---|---|
| fMRI brain activity | screening Receives: Diagnostic Test: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the area of brain activation during the participant try to perform a motor task when the hand is blocked with area of brain activation when the hand actually perform the task by using fMRI
complex hand movement: sequential repetitive thumb to other four digit opposition with the right hand
Measured: 1 year
Comparing brain activation areas while the participant imagine to perform a motor task when the hand is blocked with brain activation areas when the hand is intact, by fMRI
complex hand movement: sequential repetitive thumb to other four digit opposition with the right hand
Measured: 1 year
Secondary outcomes (1)
Comparing the area of ipsilateral cortex brain activity when the participant is intending to perform the complex motor task with the area while imagining doing the complex motor task when the arm is blocked by anesthesia.
complex hand movement: sequential repetitive thumb to other four digit opposition with the right hand
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jan 2019
- Primary completion12 Jan 2020
- Study completion12 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Regional AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesil Coskunfirat, Akdeniz University
- Investigators
- Utku A Senol, Prof., Principal investigator, Akdeniz University Radiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965338
- Sponsor's protocol ID
- 4508.24.12.2018
- Other IDs
- 4508 TSA-2019-4508
- Status last verified
- Feb 2025
- First submitted
- 20 May 2019
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le Bihan D, Karni A. Applications of magnetic resonance imaging to the study of human brain function. Curr Opin Neurobiol. 1995 Apr;5(2):231-7. doi: 10.1016/0959-4388(95)80031-x.
PubMed 7620312Ruffino C, Papaxanthis C, Lebon F. Neural plasticity during motor learning with motor imagery practice: Review and perspectives. Neuroscience. 2017 Jan 26;341:61-78. doi: 10.1016/j.neuroscience.2016.11.023. Epub 2016 Nov 25.
PubMed 27890831Osumi M, Sumitani M, Wake N, Sano Y, Ichinose A, Kumagaya S, Kuniyoshi Y, Morioka S. Structured movement representations of a phantom limb associated with phantom limb pain. Neurosci Lett. 2015 Sep 25;605:7-11. doi: 10.1016/j.neulet.2015.08.009. Epub 2015 Aug 10.
PubMed 26272300
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Brain Activity During Complex Fine Hand Movements: an fMRI Study
- ClinicalTrials.gov ID
- NCT03965338
- Acronym / sponsor ID
- 4508.24.12.2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 12 Apr 2020 (actual)
- First posted
- 29 May 2019 (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.
Brain cortex controls movement but the influence of peripheral component of movement on the cortex is not known. Functional Magnetic Resonance Imaging(fMRI) studies in stroke and fantom limb patients investigate cortex areas activated during execution and imagination of complex hand movements. These studies aim to understand the mechanisms of the motor component of movement but the results are limited as there is no effector organ in fantom limb patients and the affecting organ is damaged in stroke patients. The investigators hypothesized that the areas of the cortex that is activated to remember, set-up and order to move can be isolated from the areas that are activated during the motor component of movement. To prove this hypothesis the investigators developed a model that investigate the brain activation areas during the patient try to execute and imagine doing a complex motor task (sequential opposition with the thumb to the other four fingers) with a peripherally blocked arm. Brain fMRI in 15 right-handed patients scheduled to undergo right-hand surgery with peripheral block anesthesia will be obtained before the surgery day and just before surgery after the block. Participants will be screened when executing the task (after the block they just attempt), during rest and during they imagine doing the task. Bilateral cortex activation areas will be compared when the right hand was intact and was peripherally blocked.
There are many unknowns in the relationship between the brain-peripheric organ during movement. The investigators hope that some of these mechanisms will be identified by the new model we used in our study. The final benefit will be to develop stroke therapies and new therapies for neuropathic pain which is closely related to motor function.
Detailed description
In this study, the investigators aim to separate the cortex areas that are activated during one remember, set-up and plan and start doing a motor task from the areas that are activated during performing the motor component. The investigators hypothesized that these areas can be identified by screening areas with fMRI when participants are asked to perform a complex motor task with a hand that is completely blocked. The hypothesis is based on the fact that in a participant with a peripherally blocked arm the central component of the movement will not be affected and the activation areas that remember and plan to do a motor task can be separated from the areas that are activated when the effector organ is doing the motor task, in other words, the motor component of the task.
the investigators also aim to show;
- If there is an ipsilateral cortex activity during a participant with a peripherally blocked arm try to execute a complex motor task. The investigators know that in centrally paralyzed hands there is ipsilateral activity and there is no argument if this is an adaptive response or it is present from the beginning of the motor paralysis due to the strength of the central event of the contralateral brain area.
- If there is a difference between activation areas of the cortex during the imaginary of complex hand movements with the intact and peripherally blocked arms.
Adult patients (>18) that have been scheduled to have right-hand surgery with peripheral blockage of the arm will be evaluated for the study. The patients will be informed about all the details and the consequences of the study and patients who give written informed consent will be included in the study. Local ethics committee approval is obtained in 05.12.2018. the study will be continued until the planned 15 patients are recruited for the study.
Right-hand dominance of the patient will be confirmed by Edinburgh handedness inventory (Oldfield,1971) and scores will be recorded. In the end, the mean of the score will be obtained for the whole study population. medium-high degree right handedness will be required for inclusion to the study. The patients who do not give written informed consents, patients who use their left hand dominantly, patients who have a neurologic or psychiatric disease, the patients with hearing and visual loss, who have history of substance abuse or who had surgery in the previous 12 months, with a history of major systemic disease (ASA III and IV) , with history of drugs that alter neurologic activity, who are unable to stay at MR machine without sedation, who are accepted to have a surgery duration of more than 3 hours, and patients who have a motor deficit at their right hand that makes the performance of the motor task impossible will not be included to the study. before the MR scanning patients will have a neurologic examination to show any neurologic insult related to the pathology they will have the operation for.
All these examinations and evaluations will be made at most 10 days before surgery.
The participants will perform a given motor task of block sequence. Patients will touch the other digits by the thumb in a given order and sequence. At the same session patients, will be screened while imagining doing the same task. The orders to rest, imagine and perform the task will be given by an MRI compatible monitor- mirror set. Patients will practice the task of the experiment before the real screening sessions. The patients will be observed while in the magnet to see if they perform the task appropriately.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fMRI brain activity | – | Diagnostic Test: fMRIscreening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to have right-hand surgery with peripheral blockage of the arm
Key inclusion criteria (15 listed)
- >18 years
- have right-hand surgery with peripheral blockage of the arm
- who give written informed consent
- who are right-hand dominant Exclusion criteria: Patients
- who do not give written informed consents,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| fMRIScreening | Diagnostic test | fMRI brain activity |
Primary outcome
Compare the area of brain activation during the participant try to perform a motor task when the hand is blocked with area of brain activation when the hand actually perform the task by using fMRI
Time frame: 1 year
complex hand movement: sequential repetitive thumb to other four digit opposition with the right hand
Comparing brain activation areas while the participant imagine to perform a motor task when the hand is blocked with brain activation areas when the hand is intact, by fMRI
Time frame: 1 year
complex hand movement: sequential repetitive thumb to other four digit opposition with the right hand
1 secondary outcome
Comparing the area of ipsilateral cortex brain activity when the participant is intending to perform the complex motor task with the area while imagining doing the complex motor task when the arm is blocked by anesthesia.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 7620312Le Bihan D, Karni A. Applications of magnetic resonance imaging to the study of human brain function. Curr Opin Neurobiol. 1995 Apr;5(2):231-7. doi: 10.1016/0959-4388(95)80031-x.
- Background: PubMed 27890831Ruffino C, Papaxanthis C, Lebon F. Neural plasticity during motor learning with motor imagery practice: Review and perspectives. Neuroscience. 2017 Jan 26;341:61-78. doi: 10.1016/j.neuroscience.2016.11.023. Epub 2016 Nov 25.
- Background: PubMed 26272300Osumi M, Sumitani M, Wake N, Sano Y, Ichinose A, Kumagaya S, Kuniyoshi Y, Morioka S. Structured movement representations of a phantom limb associated with phantom limb pain. Neurosci Lett. 2015 Sep 25;605:7-11. doi: 10.1016/j.neulet.2015.08.009. Epub 2015 Aug 10.
- Individual participant dataSharing planned: No
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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.
Utku A Senol, Prof. principal investigator
Akdeniz University Radiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anaesthesia and Functional Magnetic Resonance Imaging, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 15 inclusion and 0 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: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the area of brain activation during the participant try to perform a motor task when the hand is blocked with area of brain activation when the hand actually perform the task by using fMRI (time frame: 1 year). The study lists 2 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 NCT03965338, which also lists 3 linked publications.
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 6 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.