Trials Sponsors Conditions Drugs Pricing

Conditions

Anterior Cutaneous Nerve Entrapment Syndrome Chronic Pain Syndrome Nerve Entrapment Syndrome

Keywords

ACNESSodium channel mutations

Outcome Measures

Primary Outcomes (1)

Sodium Channel 1.7 and 1.8 mutation.
Number of SCN9A and SCN10A mutations. Each mutation will be classified following one of three classes; unknown pathogenicity, probable pathogenicity, and pathogen variant.
Blood samples for SCN analysis will be taken only once after obtaining informed consent. This is the start of the study. Outpatient discharge (free of pain or no treatment options) is end of study. Treatment period can be a couple of weeks or months.

Secondary Outcomes (3)

Correlation between mutations and known cause of ACNES.
Baseline data will be obtained during first outpatient visit, before start of the treatment. The first outpatient visit takes 30 minutes (standard of care).
Correlation between mutations and pain score at start of treatment.
Baseline data will be obtained during first outpatient visit, before start of the treatment. The first outpatient visit takes 30 minutes (standard of care).
Correlation between mutations and treatment response.
Treatment response will be assessed after each treatment during the treatment period at our outpatient clinic, up to 6 weeks after treatment.

Study Arms (1)

Patients with ACNES

Patients with ACNES who fulfill the inclusion criteria.

Other: Sodium channel mutation

Interventions

Sodium channel mutationOther

Mutation of the genes SCN9A and SCN10A, which encode for Sodium channel 1.7 and 1.8.

Patients with ACNES

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

All patients who are diagnosed with ACNES and receive treatment at our outpatient clinic, and fulfill the inclusion criteria.

You may qualify if:

In order to be eligible to participate in this study, a subject must be diagnosed with ACNES and receive treatment at our outpatient clinic. Additionally, subject has to meet one of the following criteria:

Sponsors & Collaborators

Maxima Medical Center
Otherlead

Study Sites (1)

Maxima Medical Center

Veldhoven, 5504 DB, Netherlands

RECRUITING

Tom ten Have, MDCONTACT+31408887461 Tom.ten.Have@mmc.nl

Rudi Roumen, MD, PhDPRINCIPAL INVESTIGATOR

Biospecimen

Retention: SAMPLES WITH DNA

One whole blood sample

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor NeuropathyNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

Rudi Roumen, MD, PhD
Maxima Medical Center
PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom ten Have, MD

CONTACT

0408887461 Tom.ten.Have@mmc.nl

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Head of surgery, Principal Investigator

Study Record Dates

First Submitted

April 16, 2023

First Posted

May 26, 2023

Study Start

October 3, 2023

Actual (reported)

Primary Completion

June 2024

Estimated (date passed)

Sodium Channel Mutations in Patient With the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Patients with ACNES

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Patients with ACNES

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations