Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT06051656
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients(at least 18 years old).
2. Severe claw hand with less than 4 cm distance between the pulp of the fingers and palm of the hand.
3. MAS\>= 3 in wrist and hand muscles interfering with function or causing a clinical problem, due to any neurological condition.
4. Have refractory pain in wrist and hand areas with no response to the usual pain management methods including oral medication or botulinum toxin injection.
5. Patients are already candidate for cryoneurolysis to manage the pain and spasticity in their hand and wrist, based on their response to diagnostic nerve block test (DNB).
6. Ability to attend testing sessions, comply with testing protocols and provide written informed consent. For patients who physically are not able to complete the consent process, a witness may be asked to sign and confirm their willing for participation. Legal representative may be asked to help with consent process for participants who cognitively are not able to consent on their behalf.
Exclusion Criteria:
1. Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity, including previous cryoneurolysis, chemical neurolysis, neurectomy or arthroplasty.
2. Patients who received botulinum toxin in past 4 months in the same targeted muscles for cryoneurolysis, however, they may enter the study at the 4-month mark.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06051656
Study Brief:
Protocol Section:
NCT06051656