- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05947279
Examining Lateralized Aspects of Motor Control Using Non-invasive Neural Stimulation
Study Overview
Status
Intervention / Treatment
Detailed Description
Voluntary movement and sensory perception are fundamental aspects of the human experience. Senses such as visual and proprioceptive feedback inform movement by continuously providing the central nervous system with information on limb location, movement error, and task performance. However, the specific mechanisms behind how different forms of sensory information are used to adapt and generalize movement remain poorly understood.
Motor adaptation, or the modification of movement based on error feedback (Martin et al., 1996), is often elicited during rehabilitation but must be generalized to functional performance, such as activities of daily living, in order to successfully rehabilitate motor deficits following stroke. Motor adaptation and generalization are believed to occur via the integration of various forms of sensory feedback for a congruent representation of the body's position in space along with estimation of inertial properties of the limb segments for accurate specification of movement. Thus, motor adaptation is often studied within curated environments incorporating a "mis-match" between different sensory systems (i.e. a visual field shift via prism googles or a visuomotor rotation via virtual reality environment) and observing how motor plans change based on this mis-match. However, these adaptations are environment-specific and show little generalization outside of their restricted experimental setup. There remains a need for motor adaptation research that demonstrates motor learning that generalizes to other environments and movement types. This work could then inform physical and occupational therapy neurorehabilitation interventions targeted at addressing motor deficits.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brooke Dexheimer, PhD, OTD, OTR/L
- Phone Number: 563-547-0125
- Email: dexheimerb@vcu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Right-handed as determined by the short-form Edinburgh Handedness Inventory
- Between the ages of 18 and 40
Exclusion Criteria:
- Mixed- or left-handed as determined by the short-form Edinburgh Handedness Inventory
- Self-reported history of any of the following:
Seizure and/or diagnosis of epilepsy Fainting spells Concussion with loss of consciousness Ringing in the ears (tinnitus) Cochlear implants Migraines Diagnosed psychological or neurological condition Metal in the scalp
- Any previous adverse reaction to a brain stimulation technique
- Any previous adverse reaction to 3D virtual reality environments (i.e. 'cybersickness')
- Possibility of being currently pregnant (for females only)
- Current open head wound or skin condition of the scalp
- Current implanted device(s) (i.e. cardiac pacemaker)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Posterior parietal cortex group
Posterior parietal cortex group, which will receive the stimulation to their left posterior parietal cortex
|
By comparing motor adaptation reaching performance between these three groups, the investigators can examine how stimulation to each specific area of the brain modulates different aspects of motor adaptation
|
Experimental: Cerebellum group
Cerebellum group, which will receive stimulation to their right cerebellum,
|
By comparing motor adaptation reaching performance between these three groups, the investigators can examine how stimulation to each specific area of the brain modulates different aspects of motor adaptation
|
Sham Comparator: Sham group
Sham group, which will have the electrode cap placed on their head but receive no stimulation
|
By comparing motor adaptation reaching performance between these three groups, the investigators can examine how stimulation to each specific area of the brain modulates different aspects of motor adaptation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial direction error, or difference between participant's fingertip direction
Time Frame: Completion of the study visit, approx 20 minutes
|
Initial direction error, or difference between participant's fingertip direction at the timepoint of peak velocity relative to a linear path to the target.
As for time frame, this is a single-visit study.
Initial direction error will be compared during baseline reaching and following 20 minutes of non-invasive neural stimulation.
|
Completion of the study visit, approx 20 minutes
|
Initial direction error variance
Time Frame: Completion of the study visit, approx 20 minutes
|
Initial direction error variance across multiple trials.
|
Completion of the study visit, approx 20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Final position error
Time Frame: Completion of the study visit, approx 20 min
|
Secondary outcome: final position error, or distance from participant's fingertip position at the conclusion of the reach to the center of the target.
Similar to above, this measure will be compared during baseline and following 20 minutes of stimulation.
|
Completion of the study visit, approx 20 min
|
Final position error variance across multiple trials.
Time Frame: Completion of the study visit, approx 20 min
|
Final position error variance across multiple trials.
|
Completion of the study visit, approx 20 min
|
Deviation from linearity
Time Frame: Completion of the study visit, approx 20 min
|
Deviation from linearity, or a ratio of minimum and maximum displacement across the parallel and perpendicular planes of the reaching movement.
|
Completion of the study visit, approx 20 min
|
Peak tangential velocity
Time Frame: Completion of the study visit, approx 20 min
|
Peak tangential velocity, or highest tangential velocity reached during reach.
|
Completion of the study visit, approx 20 min
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HM20025761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebellum
-
The Catholic University of KoreaCompletedBalance | CerebellumKorea, Republic of
-
Klinik BavariaNot yet recruiting
-
Mclean HospitalCompletedCerebellum and Pain in Healthy Volunteers.
-
Hospices Civils de LyonCompleted
-
Xijing HospitalCompletedTranscranial Magnetic Stimulation | Drug Resistant Epilepsy | CerebellumChina
-
Universidade Federal de PernambucoUnknownCerebellar Ataxia | Balance | Cerebellum; InjuryBrazil
-
Grupo Español de Investigación en NeurooncologíaPfizerCompletedGlioblastoma Multiforme (Grade IV) of CerebellumSpain
-
HUANG XIANJIANUnknownIntracerebral Haemorrhage in CerebellumChina
-
Thorsten RudroffCompletedParkinson Disease | Brain Stimulation | CerebellumUnited States
-
Gregory K. Friedman, MDCannonball Kids' Cancer Foundation; Treovir, IncActive, not recruitingBrain Diseases | Central Nervous System Diseases | Nervous System Diseases | Neoplasms | Neoplasms by Histologic Type | Neoplasms by Site | Neoplasms, Glandular and Epithelial | Neoplasms, Germ Cell and Embryonal | Astrocytoma | Neoplasms, Neuroepithelial | Neuroectodermal Tumors | Neoplasms, Nerve Tissue | Neuroectodermal... and other conditionsUnited States
Clinical Trials on Comparing motor adaptation reaching performance
-
University of TorontoCompleted
-
University of Missouri-ColumbiaNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedParkinson Disease | Amyotrophic Lateral SclerosisUnited States
-
Escola Superior de Tecnologia da Saúde do PortoCompleted
-
Loewenstein HospitalWingate InstituteRecruiting
-
National University Health System, SingaporeNational University Hospital, Singapore; National Medical Research Council...CompletedDiabetic Neuropathies | Peripheral Nervous System DiseasesSingapore
-
University Hospital TuebingenRecruitingHereditary Spastic Paraplegia | Hereditary, Spastic Paraplegia, Autosomal DominantGermany
-
University of CincinnatiNational Institute of Neurological Disorders and Stroke (NINDS)Completed
-
University Hospital, ToulouseRecruitingCerebrovascular AccidentFrance
-
Hacettepe UniversityActive, not recruitingDuchenne Muscular DystrophyTurkey
-
Organon and CoCompleted