Non-invasive CTS Device Clinical Trial

It is hypothesized that daily wear of the study device will result in significant
improvements in patient-reported symptom severity. It is also hypothesized that the effects
from active study device treatment will be significantly greater than effects from sham
treatment. In both cases, it is hypothesized that improvements will be sustained
post-treatment.

This study is designed as a randomized, double-blind, sham-controlled, two-arm trial
consisting of an eight-week treatment period (active study device or sham), followed by one
required follow-up four weeks later (at week 12).

There are two study groups: the active device group receiving the active study device and the
sham group receiving a non-active sham device. Subjects will be informed that they have a
50:50 chance of receiving treatment or a sham. They will also be informed that if they
receive sham device, they will be offered the active device 4 weeks into the post-treatment
period. However, all subjects will not know what treatment they are on until the conclusion
of the trial.

Inclusion Criteria:

1. Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS)

2. CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 12
months OR at enrollment/baseline visit

1. CTS severity determined via AANEM criteria 13

2. Bilateral CTS accepted (worse wrist via NCS and/or BCTQ is designated as the
study wrist)

3. BCTQ SSS > 2

4. Reliable access to and ability to use Internet, Wi-Fi, or mobile data through
computers, mobile devices, laptops, and/or tablets

5. Willing to abstain from any other treatment or therapies for CTS throughout the study

6. Ability to read and write English, or has a reliable person to assist with reading and
writing English

Exclusion Criteria:

1. Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies,
ulnar nerve neuropathies)

2. Double crush syndrome

3. Cervical stenosis

4. Brachial plexopathy

5. Wrist fractures or cysts

6. Prior wrist surgeries, especially carpal tunnel release surgery

7. Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months

8. Thyroid disease

9. Rheumatoid arthritis

10. Diabetes

11. Systemic diseases

12. Connective tissue diseases

13. Fibromyalgia or chronic pain syndrome

14. Diabetic neuropathy

15. BMI > 40

16. Participation in other research studies or clinical trials currently or within the
past 2 weeks.

To assess eligibility, visit: carpaltunneltrial.com