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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2025
  • participants needed
    10
  • sponsor
    VA Office of Research and Development
Updated on 24 March 2022

Summary

The study aims to apply implanted electrical stimulation to the residual nerves in Veterans who have lost lower limbs due to diabetic peripheral neuropathy. The goal would be to provide sensation to the missing limb to improve standing, walking and balance, and improve the health of the residual limb.

Description

The goal of this project is to enhance the mobility and daily function of Veterans who have lost a lower limb due to diabetic peripheral neuropathy by providing feedback of foot-floor interactions via a Sensory Neuroprosthesis employing neural stimulation. In parallel, the investigators aim to assess the potential of this intervention to impact reports of phantom pain and improve the health and viability of the tissue of the residual limb in all recipients of the system regardless of the etiology of their limb loss.

Electrodes are surgically implanted on one to four nerves of the residual limb. An external stimulation device will send pulses to the electrodes. The participant will be asked what they feel, and to draw the location of any perceived sensation on schematic maps. A sensorized prosthesis will be worn and stimulation will be administered while the participant is engaging in various functional tasks, such as standing, walking or climbing stairs or with visual or mental distractions. The investigators will apply standard subjective pain inventories and objective physiological measures of tissue health (e.g., temperature or oxygen perfusion) to document systemic changes related to context-appropriate electrically induced sensory input.

Details
Condition Lower Extremity Amputee, Diabetic Peripheral Neuropathy
Treatment Multi contact electrode implant
Clinical Study IdentifierNCT04658693
SponsorVA Office of Research and Development
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note