Operant Conditioning for Rehabilitation After Stroke

NCT05020080 | Unknown FDA Device

• 1 other identifier: STUDY00002996
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study include:

1. 1.To test if multiple upper extremity muscles represented within a discrete primary motor cortex site reflect existing muscle synergies after stroke.
2. 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

Conditions

Stroke

Keywords

operant conditioning; motor evoked potential; transcranial magnetic stimulation; muscle synergy; motor control; motor coordination

Outcome Measures

Primary Outcomes (4)

• Change in intermuscular coordination patterns (ICoPs)

  EMGs will be recorded from 15 muscles. To assess whether wrist extensor MEP OC induces changes in the composition of intermuscular coordination patterns, non-negative matrix factorization will be applied to EMGs to identify and compare ICoPs.

  before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively

• Change in motor evoked potential (MEP)

  To measure the amount of the corticospinal excitability of the target muscle (extensor carpi radialis) and its antagonist (flexor carpi radialis), MEPs will be elicited while the participant provides \~30% maximum voluntary contraction level of each muscle background electromyographic (EMG) signals. For all trials, transcranial magnetic stimulation at \~10% above active motor threshold at the optimum location of the cortex will be used to elicit the MEP.

  before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively

• Change in Fugl-Meyer Assessment (FMA) score

  To measure severity of motor impairment after stroke, FMA will be performed in the human upper extremity. FMA is commonly used to assess severity of motor impairment and motor recovery. The maximum FMA upper extremity motor score is 66 (i.e., 0: complete motor impairment; 66: normal motor performance). Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).

  Time Frame: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively

• Change in Action Research Arm Test (ARAT) score

  To measure motor function after stroke, ARAT will be performed in the human upper extremity. 19 Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch, and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).

  before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively

Secondary Outcomes (1)

• Change in force errors that occur during isometric wrist force tracking tasks

  before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively

Study Arms (1)

ECR MEP conditioning - Stroke

EXPERIMENTAL

MEP operant conditioning of ECR in stroke survivors

Other: Operant conditioning of motor evoked potentials

Interventions

Operant conditioning of motor evoked potentials OTHER

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.

ECR MEP conditioning - Stroke

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female whose age range between 40 and 75
• no known neurological injuries

You may not qualify if:

• have an orthopedic disorder involving upper limbs;
• 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.
• 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);

Sponsors & Collaborators

• University of Houston: lead
• National Center of Neuromodulation for Rehabilitation: collaborator

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 25856485 BACKGROUND

• 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.

  PMID: 25762917 BACKGROUND

• 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.

  PMID: 19828310 BACKGROUND

• 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.

  PMID: 23155178 BACKGROUND

• 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.

  PMID: 25717296 BACKGROUND

• 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.

  PMID: 30625010 BACKGROUND

• 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.

  PMID: 30207863 BACKGROUND

• 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.

  PMID: 30123249 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jinsook Roh, Ph.D.

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinsook Roh, PhD

CONTACT

7137432578; jroh@Central.UH.EDU

Manuel A Portilla-Jiménez, MS, BME

CONTACT

3467194921; maporti4@cougarnet.uh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 25, 2021
• Study Start: January 13, 2022
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)