Feasibility of Sensory Feedback for Lower Limb Amputees
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/26/2018 |
| Start Date: | November 5, 2015 |
| End Date: | August 1, 2020 |
| Contact: | Melissa Schmitt, RN, BSN |
| Email: | Melissa.Schmitt@va.gov |
| Phone: | 216-791-3800 |
The purpose of this study is to evaluate the effectiveness of providing sensation of the
missing limb by applying small electrical current directly to the remaining sensory nerves
via implanted stimulating electrodes. These small electrical currents cause the nerves to
generate signals that are then transferred to your brain just like the information about the
foot and lower limb used to be transferred to your brain prior to the amputation.
missing limb by applying small electrical current directly to the remaining sensory nerves
via implanted stimulating electrodes. These small electrical currents cause the nerves to
generate signals that are then transferred to your brain just like the information about the
foot and lower limb used to be transferred to your brain prior to the amputation.
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.
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.
Inclusion Criteria:
- Adults age 18 or greater
- Chronic, medically stable ( > 3 months) unilateral trans-tibial or trans-femoral
amputation
- Potential user of trans-tibial or trans-femoral prostheses for standing or walking
- 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:
- Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%).
- Significant vascular disease
- Chronic skin ulcerations
- Significant history of poor wound healing
- Significant history of uncontrolled infections
- Active infection
- Significant pain in the residual or phantom limb
- Pregnancy
- Inability to speak English
- Expectation that MRI will be required at any point for the duration of study or while
percutaneous leads are in place
- Arthritis in the area of implant
- History of vestibular or movement disorders that would compromise balance or walking
- Class II or III obesity (Body Mass Index > 35)
- Poor surgical candidate
- Uncontrolled depression, psychoses or cognitive impairments
We found this trial at
1
site
Cleveland, Ohio 44106
Principal Investigator: Ronald Triolo, PhD
Phone: 216-791-3800
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