NCT03965338

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2020

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

May 20, 2019

Last Update Submit

February 4, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    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.

    1 year

Study Arms (1)

fMRI brain activity

screening

Diagnostic Test: fMRI

Interventions

fMRIDIAGNOSTIC_TEST

Screening

fMRI brain activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled to have right-hand surgery with peripheral blockage of the arm

You may qualify if:

  • \>18 years
  • have right-hand surgery with peripheral blockage of the arm
  • who give written informed consent

You may not qualify if:

  • who do not give written informed consents,
  • use their left hand dominantly,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AkdenizU

Antalya, 07058, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 7620312BACKGROUND
  • 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.

    PMID: 27890831BACKGROUND
  • 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.

    PMID: 26272300BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Utku A Senol, Prof.

    Akdeniz University Radiology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 29, 2019

Study Start

January 1, 2019

Primary Completion

January 12, 2020

Study Completion

April 12, 2020

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations