Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658693
• Other study ID #: A3566-R
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: September 2, 2027

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Ronald Triolo, PhD
• Phone: (216) 791-3800
• Email: ronald.triolo[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with above and below the knee limb loss. The investigators will implanted stimulating electrodes to send small electrical currents to the remaining nerves. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how the information about your foot and lower limb used to be transferred to the brain prior to your limb loss. Additionally, there is the option to have muscle recording electrodes implanted within the muscles of the lower limb with the goal to develop a motor controller that would allow the user to have intuitive control of a robotic prosthetic leg.

Description:

Electrodes are surgically implanted on one to four nerves of the residual limb. Intramuscular recording electrodes can be implanted in the lower limbs and hip muscles in order to obtain electromyography (EMG) signals. The EMG recordings will be used to develop an algorithm which can operate an advanced robotic prosthesis in which the prosthesis joint(s) movements could be controlled. An external wearable stimulation device controls the delivery of electrical pulses to the implanted system. An instrumented prosthesis will be developed such that perceived sensations would correspond to prosthesis interactions with the floor. The instrumented prosthesis will be worn while the participant is engaging in various functional tasks, such as standing, walking or climbing stairs or with visual or mental distractions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2, 2027
• Est. primary completion date: September 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic, medically stable lower limb amputation due to diabetes or insensate foot due to Diabetic peripheral neuropathy
• Being ambulatory and ability to stand or walk with prosthesis or orthosis
• Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials (SEP) and the like
• Good skin integrity and personal hygiene
• Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
• Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule

Exclusion Criteria:

• Active pressure ulcers or chronic skin ulcerations
• Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%)
• Significant vascular disease
• Significant history of poor wound healing
• Significant history of uncontrolled infections
• Active infection
• Significant pain in the foot, residual or phantom limb
• Pregnancy
• Inability to speak English: The study design requires the subject to communicate and describe the elicited sensations in their lower limb
• History of vestibular or movement disorders that would compromise balance or walking
• Class II or III obesity (Body Mass Index > 35)
• Uncontrolled depression, psychoses or cognitive impairments. Subjects with unstable mental illness or severe cognitive impairments may be unable to comply with a long term study schedule
• Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place. At this time MRI is contraindicated, subjects who require regular MRI should not enroll
• Arthritis in the area of implant- Inflammation or stiffness in the area of implant could limit placement of the electrodes

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Lower Extremity Amputee
• Peripheral Nervous System Diseases

Intervention

Device:
• Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode
See arm description

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulation thresholds	Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.	9 months post implant
Primary	Functional Gait Assessment (FGA)	The Functional Gait Assessment is a 10 task test that measures postural stability. Each task is scored from 0 -3 with 0 indicating severe impairment in the task and 3 indicating normal ambulation. The scores are combined to give a total score. The maximum score is 30. A higher score indicates a better outcome.	6 months post implant
Secondary	Neuropathic Pain Syndrome Inventory (NPSI)	The NPSI is comprised of five subscales, each representing different dimensions of neuropathic pain: burning spontaneous pain (burning), pressing spontaneous pain (pressing), paroxysmal pain (paroxysmal), evoked pain (evoked), and paresthesia/dysesthesia Each area subscale is scored between 0-10. The scores are not combined, but are able to report on different aspects of neuropathic pain. A higher score indicates a worse outcome.	4 years post implant

External Links

•   VA Center of Excellence website listing this and other ongoing studies.