Technical Feasibility
a. What are the technologies needed?
- Protein biomarker sensors
-Electrical stimulation mechanism
b. What are the challenges?
-Placing the marker in the correct spot to connect to the vagus nerve
- The surgery would be invasive and require an expert to accomplish
- The electrode must send the perfect amount of electrical stimulation to the nerve
- there is currently no technology available for detecting cartilage oligomeric matrix protein
c. What could go wrong?
- The sensor could break down, causing the electrode to malfunction and either over or under stimulate the vagus nerve
- The electrode could break and either stop working or send unwanted electrical signals
Clinical Feasibility.
a. Given the technical feasibility it work in the clinic?
- It would require surgeons, but the device would be feasible for severe cases of arthritis
- The device could be an effective therapy for severe arthritis sufferers who have exhausted all of their options for noninvasive therapies
b. What are the clinical risks?
- The surgical implantation could become infected during the healing process
- Contamination of the bloodstream from the metals and technologies used
- Unwanted vagus nerve stimulation
- The human body may not be able to handle the surgery
c. Have similar products been in a clinical trial? How long was the trial?
- Electrical stimulation has been tested to treat arthritis in the past. The treated arthritis patients were treated three times a week for 4 weeks and then their pain scores and mobility were tested. For treated patients, the group of 14 experienced an overall change of -.54 on the WOMAC Pain Score which is a scale from 5 to 25. The control group however had an average increase of +1.4 on the scale.
-There is currently no clinical trials for detection of the cartilage oligomeric matrix protein
- Only one of the clinical trials available used electrical stimulation to treat arthritis before surgical intervention. The rest of the related trials are testing the effects of electrical stimulation during the recovery process after a knee-replacement.
- There is one clinical trial done in Europe that tested specifically vagus nerve stimulation's effects on arthritis however there were no results posted.
BME 100 Spring 2018
