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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • AkdenizU

    Antalya, 07058

Other trials in Turkey (Türkiye)

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;

  1. 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.
  2. 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 groups in NCT03965338
Study groupRoleWhat they receive
fMRI brain activityscreening
Receives: Diagnostic Test: fMRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  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.

  1. First posted29 May 2019
  2. Study start1 Jan 2019
  3. Primary completion12 Jan 2020
  4. Study completion12 Apr 2020

Resources

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)
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 7620312
  • Ruffino 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 27890831
  • Osumi 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

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.

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