Recruiting

Operant Conditioning

Sponsor:

University of Houston

Code:

NCT05020080

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Operant conditioning of motor evoked potentials

Study Details

Brief summary:

The purposes of this study include:

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

Conditions

Stroke

Study ID

NCT05020080

Start date

Jan 13, 2022

Status verified date

Nov, 2023

Completion date

Jul 12, 2024

Anticipated

Primary completion date

Jul 12, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Inclusion criteria for aged matched healthy group

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

Exclusion criteria for aged matched healthy group

  • 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.

Inclusion criteria for stroke group

  • 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 for stroke group

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: ECR MEP conditioning - Stroke

MEP operant conditioning of ECR in stroke survivors

Interventions

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.

Primary outcome measure

  • Change in intermuscular coordination patterns (ICoPs) [ 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 motor evoked potential (MEP) [ 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 Fugl-Meyer Assessment (FMA) score [ Time Frame: 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 [ Time Frame: before any training, after the 12th and 24th conditioning sessions, respectively, and 1 and 3 months after the 24th conditioning, respectively ]

Central Contacts and Locations

Central contacts

Jinsook Roh, PhD

7137432578jroh@Central.UH.EDU

Manuel A Portilla-Jiménez, MS, BME

3467194921maporti4@cougarnet.uh.edu

Locations

University of Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Jinsook Roh, PhD

713-743-2578jroh@central.uh.edu

Manuel A Portilla-Jiménez, MS, BME

3467194921maporti4@cougarnet.uh.edu

More Information

Sponsor

University of Houston

Last update posted

Nov 29, 2023

Last verified

Nov, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of Houston on 2023-11-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.