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

Primary Purpose

Lower Extremity Amputee, Diabetic Peripheral Neuropathy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode

About this trial

This is an interventional device feasibility trial for Lower Extremity Amputee focused on measuring Sensory Feedback, Limb Loss, Prosthesis User

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic, medically stable lower limb amputation due to diabetes or insensate foot due to DPN
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

Sites / Locations

Louis Stokes VA Medical Center, Cleveland, OHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multi contact electrode implant and implanted electromyography recording electrodes

Arm Description

Fifteen subjects with lower limb amputation will receive implanted multicontact stimulating nerve cuff electrodes connected to temporary percutaneous leads. During experimental testing, a small amount of stimulation will be applied to the nerves through the contacts of the multichannel cuff electrode.

Outcomes

Primary Outcome Measures

Stimulation thresholds

Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04658693

First Posted

November 20, 2020

Last Updated

January 23, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT04658693

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 2, 2021 (Actual)

Primary Completion Date

September 2, 2027 (Anticipated)

Study Completion Date

September 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lower Extremity Amputee, Diabetic Peripheral Neuropathy

Keywords

Sensory Feedback, Limb Loss, Prosthesis User

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The project will take the form of a series of controlled single-subject feasibility and proof-of-concept studies with repeated measures. Subjects will act as their own concurrent controls with and without sensory stimulation, as well as their own longitudinal (historical) controls pre- and post-implementation of the Sensory Neuroprosthesis.

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multi contact electrode implant and implanted electromyography recording electrodes

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode

Other Intervention Name(s)

Sensory Neuroprosthesis

Intervention Description

See arm description

Primary Outcome Measure Information:

Title

Stimulation thresholds

Description

Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.

Time Frame

9 months post implant

Title

Functional Gait Assessment (FGA)

Description

Time Frame

6 months post implant

Secondary Outcome Measure Information:

Title

Neuropathic Pain Syndrome Inventory (NPSI)

Description

Time Frame

4 years post implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ronald Triolo, PhD

Phone

(216) 791-3800

ronald.triolo@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Aarika Sheehan, DPT

Phone

(216) 791-3800

Ext

65832

Aarika.Sheehan@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Triolo, PhD

Organizational Affiliation

Louis Stokes VA Medical Center, Cleveland, OH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Louis Stokes VA Medical Center, Cleveland, OH

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-1702

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neal S Peachey, PhD

Phone

216-421-3221

neal.peachey@va.gov

First Name & Middle Initial & Last Name & Degree

Holly B Henry

Phone

(216) 791-3800

Ext

64657

holly.henry@va.gov

First Name & Middle Initial & Last Name & Degree

Ronald Triolo, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Deidentified data will be provided upon request.

Links:

URL

https://www.aptcenter.research.va.gov/

Description

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

Learn more about this trial

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

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