Feasibility of Sensory Feedback for Lower Limb Amputees

Amputation Clinical Trial

Official title:

Feasibility of Sensory Feedback for Lower Limb Amputees

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03409133
• Other study ID #: 15046-H27
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2015
• Est. completion date: September 1, 2027

Study information

• Verified date: May 2023
• Source: Louis Stokes VA Medical Center
• Contact: Aarika Sheehan, PT, DPT
• Phone: 216-791-3800
• Email: Aarika.Sheehan[@]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 lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation.

Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable 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. An external wearable device controls the delivery of electrical pulses to the implanted system. The participant will be asked to verbally describe the perceived sensations and highlight their locations on a drawing of a foot presented to them on an electronic screen. An instrumented prosthesis will be developed such that perceived sensations would correspond to prosthesis interactions with the floor. This instrumented prosthesis, also known as a sensory neuroprosthesis, 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.

Intramuscular recording electrodes can be implanted in the lower limb(s) and/or hip muscles in order to obtain electromyography (EMG) signals. The EMG recordings from the residual muscles will be used to develop an algorithm which can operate an advanced robotic prosthesis in which the movement of the joint(s) could be controlled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Stimulating nerve electrodes and intramuscular recording electrodes
See Arm Description

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Louis Stokes VA Medical Center	Case Western Reserve University, United States Department of Defense

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.	1 year post implant