Peripheral Nerve Injuries
Conditions
Brief summary
The aim of this clinical trial is to evaluate the efficacy of tesamorelin as a therapy for peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will result in faster and more substantial recovery of motor and sensory function following surgical repair of injured peripheral nerves. Patients with upper extremity nerve injuries will be randomly assigned to receive either tesamorelin treatment or no treatment. Assessments for nerve regeneration, muscle function, and sensation will be conducted every three months for a total of 12 months. Outcomes in patients receiving tesamorelin will be compared to those in the untreated group to determine the effectiveness of tesamorelin as a therapeutic intervention for nerve injuries.
Detailed description
This is a randomized, double-blinded, clinical trial assessing the efficacy of tesamorelin as a therapy to improve functional recovery following peripheral nerve injury. Tesamorelin is a drug that stimulates increased production of growth hormone, and growth hormone has been shown to improve nerve regeneration and functional recovery in animal studies. A total of 36 participants with repaired ulnar nerve lacerations will be enrolled, of which 18 will be randomly assigned to receive the study drug and 18 will receive no treatment. To minimize bias, outcome assessors and the biostatistician analyzing the data will be blinded to the treatment assignments. Following enrollment, each participant will have 12 monthly follow-up visits during which participants will undergo testing to assess recovery. Outcome assessments will include clinical exams, electrodiagnostic studies and questionnaires. The total duration of the study is expected to be 4 years.
Interventions
DRUGTesamorelin 2 Milligrams (MG)
Daily self-administered study drug
Sponsors
United States Department of Defense
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ulnar nerve laceration at the wrist, repaired primarily
Exclusion criteria
* Certain cancers (active or in the past) * Uncontrolled diabetes or hypertension * Certain pituitary problems * Oral contraceptives * Pregnancy * Drug or alcohol dependence * Psychosocial issues that would limit participation and compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-point chuck pinch test | 12 months | Pinch strength measure as measured by a pinch gauge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Michigan Hand Questionnaire score | 12 months | Questionnaire |
| Amplitude of response | 12 months | Nerve conduction study measure |
| Latency of response | 12 months | Nerve conduction study measure |
| Disability of the Arm, Shoulder, and Hand (DASH) score | 12 months | Questionnaire |
| Modified British Medical Research Council (MBMRC) sensory grading (S0-S4) | 12 months | Standardized clinical assessment of sensory function using 2-point discrimination and monofilament testing. S0 indicates no recovery and S4 indicates full recovery. |
| Modified British Medical Research Council (MBMRC) motor grading (M0-M5) | 12 months | Standardized clinical assessment of motor function. M0 indicates no muscle contraction and M5 indicates active range of motion against strong resistance. |
| Velocity of response | 12 months | Nerve conduction study measure |
Countries
United States
Contacts
Primary ContactSami Tuffaha, MD
Outcome results
None listed