Neural Operant Conditioning

NCT06113965 | Withdrawn DMC

• 1 other identifier: StudyID00000301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if operant conditioning can reduce spasticity in order to improve walking in stroke patient. The main questions it aims to answer are:

• Can participants self-regulate reflex excitability
• Can participants self-regulate reflex, reduce spasticity and improve walking Participants will undergo surface stimulation to evoke spinal reflexes and will be asked to control these reflexes therefore reducing spasticity. Researchers will compare result to able bodied participants to see if \[insert effects\]

Conditions

Stroke; Chronic Stroke; Gait, Hemiplegic; Gait, Spastic; Walking, Difficulty

Outcome Measures

Primary Outcomes (1)

• Surface electromyographic recording of leg muscles

  Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation

  baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment

Secondary Outcomes (4)

• 10 meter walk test

  baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment

• quadriceps pendulum test

  baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment

• Five Times Sit to Stand Test

  baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment

• Transcranial Magnetic Stimulation (TMS)

  Baseline, Week 12 - end of treatment

Study Arms (1)

Experimental: Post-stroke Stiff-Knee Gait Participants

EXPERIMENTAL

Individuals with post-stroke Stiff-Knee gait

Device: Peripheral Nerve Stimulation

Interventions

Peripheral Nerve Stimulation DEVICE

Electrical stimulation of peripheral nerves to measure resulting gait kinematics and surface muscle activity

Experimental: Post-stroke Stiff-Knee Gait Participants

Eligibility Criteria

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

You may qualify if:

• Sign and date consent form
• At least 3 months since stroke event
• Over 18 years of age at time of eligibility
• Ability to stand upright and walk for at least 5 minutes
• Premorbidly independent
• Mild to moderate gait impairment
• Reduced knee flexion during walking relative to the unimpaired side
• Unilateral hemiparesis of the lower limbs
• Ability to evoke muscle responses through peripheral nerve stimulation, spinal cord stimulation, and transcranial magnetic stimulation
• Medically stable
• Skin intact on hemiparetic leg, abdomen, and scalp
• Ability to evoke muscle responses and/or reflex responses through peripheral nerve stimulation, spinal cord stimulation, and/or transcranial magnetic stimulation

You may not qualify if:

• Co-existing neurological condition other than prior stroke involving the hemiparetic lower limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
• History of lower limb musculoskeletal injury
• Functionally relevant osteoarthritis and weight bearing restriction
• Functionally relevant polyneuropathy resulting in lack of sensation in the lower leg
• Functionally relevant cognitive impairment
• Functionally relevant vision impairment
• Pregnant
• Botox injection to the ipsilateral leg in the last 12 weeks or taking oral anti-spasticity medications
• Taking part in physical therapy for any walking-related impairment
• Cardiac pacemaker or other implanted electronic systems
• Uncontrolled seizure disorder
• Use of seizure lowering threshold medications and the discretion of the study physician
• Deficits in communication that interfere with reasonable study participation
• Severely impaired cognition and communication
• Severe lower limb pain

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (11)

• Burpee JL, Lewek MD. Biomechanical gait characteristics of naturally occurring unsuccessful foot clearance during swing in individuals with chronic stroke. Clin Biomech (Bristol). 2015 Dec;30(10):1102-7. doi: 10.1016/j.clinbiomech.2015.08.018. Epub 2015 Sep 2.

  PMID: 26371855 BACKGROUND

• Akbas T, Kim K, Doyle K, Manella K, Lee R, Spicer P, Knikou M, Sulzer J. Rectus femoris hyperreflexia contributes to Stiff-Knee gait after stroke. J Neuroeng Rehabil. 2020 Aug 26;17(1):117. doi: 10.1186/s12984-020-00724-z.

  PMID: 32843057 BACKGROUND

• Li S, Francisco GE. New insights into the pathophysiology of post-stroke spasticity. Front Hum Neurosci. 2015 Apr 10;9:192. doi: 10.3389/fnhum.2015.00192. eCollection 2015.

  PMID: 25914638 BACKGROUND

• Li S, Francisco GE, Zhou P. Post-stroke Hemiplegic Gait: New Perspective and Insights. Front Physiol. 2018 Aug 2;9:1021. doi: 10.3389/fphys.2018.01021. eCollection 2018.

  PMID: 30127749 BACKGROUND

• Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.

  PMID: 18164331 BACKGROUND

• Dehnadi Moghadam A, Hasanzadeh H, Dehnadi Moghadam F. Evaluation of the Effect of Intranasal Lidocaine in the Treatment of Spasticity in Patients with Traumatic Brain Injury. Anesth Pain Med. 2021 Aug 15;11(4):e115849. doi: 10.5812/aapm.115849. eCollection 2021 Aug.

  PMID: 34692437 BACKGROUND

• Navarrete-Opazo AA, Gonzalez W, Nahuelhual P. Effectiveness of Oral Baclofen in the Treatment of Spasticity in Children and Adolescents With Cerebral Palsy. Arch Phys Med Rehabil. 2016 Apr;97(4):604-618. doi: 10.1016/j.apmr.2015.08.417. Epub 2015 Aug 28.

  PMID: 26321489 BACKGROUND

• Wolpaw JR, Braitman DJ, Seegal RF. Adaptive plasticity in primate spinal stretch reflex: initial development. J Neurophysiol. 1983 Dec;50(6):1296-311. doi: 10.1152/jn.1983.50.6.1296.

  PMID: 6663327 BACKGROUND

• Wolpaw JR, Lee CL. Motoneuron response to dorsal root stimulation in anesthetized monkeys after spinal cord transection. Exp Brain Res. 1987;68(2):428-33. doi: 10.1007/BF00248809.

  PMID: 3480233 BACKGROUND

• Chen XY, Wolpaw JR. Operant conditioning of H-reflex in freely moving rats. J Neurophysiol. 1995 Jan;73(1):411-5. doi: 10.1152/jn.1995.73.1.411.

  PMID: 7714584 BACKGROUND

• Thompson AK, Chen XY, Wolpaw JR. Acquisition of a simple motor skill: task-dependent adaptation plus long-term change in the human soleus H-reflex. J Neurosci. 2009 May 6;29(18):5784-92. doi: 10.1523/JNEUROSCI.4326-08.2009.

  PMID: 19420246 BACKGROUND

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Sulzer, PhD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James Sulzer, PhD

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 2, 2023
• Study Start: December 31, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 10, 2025

Record last verified: 2025-01

Locations

US (1)