Feasibility of Sensory Feedback for Lower Limb Amputees
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Multi contact electrode implant Ten 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. |
Device: Multi contact electrode implant
See Arm Description
|
Outcome Measures
Primary Outcome Measures
- Sensor-Driven Sensation [9 months]
Standing and treadmill trials using instrumented prosthesis with and without sensory stimulation active.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Louis Stokes VA Medical Center | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- Louis Stokes VA Medical Center
- Case Western Reserve University
- United States Department of Defense
Investigators
- Principal Investigator: Ronald Triolo, PhD, Louis Stokes VA Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15046-H27