Neural Operant Conditioning

NCT ID: NCT06113965

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2028-05-31

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]

Detailed Description

The study purpose is to investigate the possibility and later effect of spinal reflex self-regulation in post-stroke stiff-knee gait. The intervention will consist of direct current surface stimulation of the peripheral nerves using electrical stimulation. Stimulation will evoke a motor response that will be collected through surface EMG electrodes and processed to depict a measure of the response as feedback to the participant to complete the loop of operant conditioning. The participant will attempt to modulate their responses over multiple sessions to cause this depiction to either increase or decrease its value depending on an established target.

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Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Post-stroke Stiff-Knee Gait Participants

Individuals with post-stroke Stiff-Knee gait

Group Type: EXPERIMENTAL

Peripheral Nerve Stimulation

Intervention Type: DEVICE

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

Interventions

Peripheral Nerve Stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Sign and date consent form

2. At least 3 months since stroke event

3. Over 18 years of age at time of eligibility

4. Ability to stand upright and walk for at least 5 minutes

5. Premorbidly independent

6. Mild to moderate gait impairment

7. Reduced knee flexion during walking relative to the unimpaired side

8. Unilateral hemiparesis of the lower limbs

9. Ability to evoke muscle responses through peripheral nerve stimulation, spinal cord stimulation, and transcranial magnetic stimulation

10. Medically stable

11. Skin intact on hemiparetic leg, abdomen, and scalp

12. Ability to evoke muscle responses and/or reflex responses through peripheral nerve stimulation, spinal cord stimulation, and/or transcranial magnetic stimulation

Exclusion Criteria

1. Co-existing neurological condition other than prior stroke involving the hemiparetic lower limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).

2. History of lower limb musculoskeletal injury

3. Functionally relevant osteoarthritis and weight bearing restriction

4. Functionally relevant polyneuropathy resulting in lack of sensation in the lower leg

5. Functionally relevant cognitive impairment

6. Functionally relevant vision impairment

7. Pregnant

8. Botox injection to the ipsilateral leg in the last 12 weeks or taking oral anti-spasticity medications

9. Taking part in physical therapy for any walking-related impairment

10. Cardiac pacemaker or other implanted electronic systems

11. Uncontrolled seizure disorder

12. Use of seizure lowering threshold medications and the discretion of the study physician

13. Deficits in communication that interfere with reasonable study participation

14. Severely impaired cognition and communication

15. Severe lower limb pain

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MetroHealth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James Sulzer

James Sulzer, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Sulzer, PhD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

MetroHealth Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26371855 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32843057 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25914638 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30127749 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18164331 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34692437 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26321489 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6663327 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3480233 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7714584 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19420246 (View on PubMed)

Other Identifiers

StudyID00000301

Identifier Type: -

Identifier Source: org_study_id