Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
20 participants
INTERVENTIONAL
2022-01-13
2024-07-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. To test if multiple upper extremity muscles represented within a discrete primary motor cortex site reflect existing muscle synergies after stroke.
2. To test if altered muscle synergies and intermuscular coordination are malleable to motor evoked potential conditioning that induces corticospinal plasticity for the targeted muscle, wrist extensor carpi radialis
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
For the aim 1 of the project, MEPs elicited by TMS will be applied at the hot spot for the wrist ECR. EMG signal from 15 UE muscle will be collected simultaneously during isometric force generation tasks. This aim will enroll 10 age-matched (age of 40-75 yo) healthy adult and 10 adult (age of 40-75 yo) stroke survivors. Each participant will have a single measurement session.
For the aim 2 of the project, 4 randomized out of 10 stroke survivors will perform operant conditioning method of the wrist ECR; also, assessment of the intermuscular coordination, UE Fugl-Meyer (FM), and Action Research Arm Test (ARAT) will be performed. Participants will have three visits per week for 10 weeks for training session. Finally, to test retention of the intervention effect, they will perform two assessment sessions one and three months after finishing the training.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ECR MEP conditioning - Stroke
MEP operant conditioning of ECR in stroke survivors
Operant conditioning of motor evoked potentials
MEPs elicited by TMS will be applied at the hot spot for the wrist extensor carpi radialis. During training trials, participants will be asked to increase the size of their MEP response. During assessment trials, a physical therapist or occupational therapist will rate the functional level of arm impairment using FMA and ARAT.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Operant conditioning of motor evoked potentials
MEPs elicited by TMS will be applied at the hot spot for the wrist extensor carpi radialis. During training trials, participants will be asked to increase the size of their MEP response. During assessment trials, a physical therapist or occupational therapist will rate the functional level of arm impairment using FMA and ARAT.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* no known neurological injuries
* male or female hemiparetic chronic stroke survivors;
* age ranging between 40-75 year;
* with single unilateral ischemic or hemorrhagic middle cerebral artery stroke;
* neurologically stable for \>6 months;
* have an expectation that current medication will be maintained without changes for at least 3 months. Stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted;
* with moderate-to-severe impairments (FMA\<45/66);
* with weak wrist extension (i.e., \<4 by manual muscle strength test);
* eligible to receive transcranial magnetic stimulation (TMS), and extensor carpi radialis (ECR) motor evoked potential (MEP) must be present in the more affected arm;
* without severe spasticity (Modified Ashworth (MA) \<4);
* have not received botulinum toxin on the impaired arm within 3 months.
Exclusion Criteria
* have a history of any neurologic disease;
* have any history of epilepsy of the potential participants and/or their family members;
* had an adverse reaction to TMS;
* are unable to consent;
* are pregnant.
* have an orthopedic disorder involving upper limbs;
* have no measurable MEP elicited in the ECR;
* unable to produce any voluntary ECR EMG activity;
* cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol (Montreal Cognitive Assessment (MoCA) score \< 26);
* a history of another neurologic disease;
* a history of vertigo;
* a history of vestibular or cochlear dysfunction;
* have a history of convulsion or a seizure;
* anesthesia of joint position sense in upper limbs;
* are pregnant or have a chance that they might be (self-reported);
* have metal in the brain/skull (except titanium; e.g. splinters, fragments, clips, etc.);
* have cochlear implants;
* have an implanted neurostimulator (DBS, epidural/subdural, VNS);
* have a cardiac pacemaker or intracardiac lines or metal in the body;
* have a medication infusion device;
* are taking any medications to treat mental illness;
* have spinal or ventricular derivations;
* had an adverse reaction to TMS.
40 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Center of Neuromodulation for Rehabilitation
OTHER
University of Houston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jinsook Roh
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jinsook Roh, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Houston
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Houston
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Ting LH, Chiel HJ, Trumbower RD, Allen JL, McKay JL, Hackney ME, Kesar TM. Neuromechanical principles underlying movement modularity and their implications for rehabilitation. Neuron. 2015 Apr 8;86(1):38-54. doi: 10.1016/j.neuron.2015.02.042.
McMorland AJ, Runnalls KD, Byblow WD. A neuroanatomical framework for upper limb synergies after stroke. Front Hum Neurosci. 2015 Feb 16;9:82. doi: 10.3389/fnhum.2015.00082. eCollection 2015.
Tresch MC, Jarc A. The case for and against muscle synergies. Curr Opin Neurobiol. 2009 Dec;19(6):601-7. doi: 10.1016/j.conb.2009.09.002. Epub 2009 Oct 12.
Roh J, Rymer WZ, Perreault EJ, Yoo SB, Beer RF. Alterations in upper limb muscle synergy structure in chronic stroke survivors. J Neurophysiol. 2013 Feb;109(3):768-81. doi: 10.1152/jn.00670.2012. Epub 2012 Nov 14.
Roh J, Rymer WZ, Beer RF. Evidence for altered upper extremity muscle synergies in chronic stroke survivors with mild and moderate impairment. Front Hum Neurosci. 2015 Feb 11;9:6. doi: 10.3389/fnhum.2015.00006. eCollection 2015.
Thompson AK, Fiorenza G, Smyth L, Favale B, Brangaccio J, Sniffen J. Operant conditioning of the motor-evoked potential and locomotion in people with and without chronic incomplete spinal cord injury. J Neurophysiol. 2019 Mar 1;121(3):853-866. doi: 10.1152/jn.00557.2018. Epub 2019 Jan 9.
Thompson AK, Cote RH, Sniffen JM, Brangaccio JA. Operant conditioning of the tibialis anterior motor evoked potential in people with and without chronic incomplete spinal cord injury. J Neurophysiol. 2018 Dec 1;120(6):2745-2760. doi: 10.1152/jn.00362.2018. Epub 2018 Sep 12.
Thompson AK, Favale BM, Velez J, Falivena P. Operant Up-Conditioning of the Tibialis Anterior Motor-Evoked Potential in Multiple Sclerosis: Feasibility Case Studies. Neural Plast. 2018 Jul 15;2018:4725393. doi: 10.1155/2018/4725393. eCollection 2018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00002996
Identifier Type: -
Identifier Source: org_study_id