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Hidden nerve disease found in carpal tunnel patients?

NCT ID NCT06414746

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study in Russia checked how many people with carpal tunnel syndrome also have a rare inherited nerve condition called hereditary transthyretin amyloidosis. Researchers reviewed medical records of 721 patients and will test some for the genetic mutation. The goal is to understand how common this hidden disease is in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors identify hidden cases of hereditary transthyretin amyloidosis earlier in patients with carpal tunnel syndrome.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve health. Results may not apply outside Russia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

721 people

The number who actually took part.

Started

Dec 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This multicenter observational study will retrospectively include 1300 consecutive adult patients diagnosed with CTS and having bilateral involvement in Russia from the earliest date of diagnosis to a later one within the specified time period who are observed and monitored at 20 participating sites, including approximately \~800 patients with CTS and high suspicion of having ATTR PN who will be enrolled in the prospective phase.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: for the retrospective phase are: 1. Patients with the established diagnosis of CTS. 2. Bilateral involvement of carpal tunnel established between the 1st January 2021 and the 31st December 2024 (both patients who underwent CTS surgical intervention and without it are enrolled). 3. Age ≥ 18 years at the time of CTS diagnosis. 4. Provided written informed consent for the prospective phase of the study (including molecular genetic testing). 5. Presence of ≥1 of the following features (red flags): a. CIDP or polyneuropathy of unknown etiology in the family history; b. Spinal canal stenosis of the lumbar region; c. Autonomic dysfunction, defined by the presence of ≥1 of the following symptoms - i. Gastrointestinal complaints (constipation, chronic diarrhea, or both); ii. Erectile dysfunction; iii. Orthostatic hypotension; d. Gait disorders; e. Sweating disorders, anhidrosis. f. Paresthesia and burning of the skin of the distal extremities g. Distal symmetrical paresis h. Hypotrophy and hypotension of limb muscles, areflexia i. Biceps tendon rupture j. Aortic valve stenosis k. Diagnosis of HFpEF l. Unexplained weight loss ≥5 kilos at any timepoint since the onset of symptoms of CTS; m. Left ventricular hypertrophy (based on electro- or echocardiographic criteria documented in the patient's medical record); n. Heart rhythm disorders; o. Renal abnormalities, defined by ≥1 of the following features - i. Documented diagnosis of chronic kidney disease (CKD); ii. Decreased estimated glomerular filtration rate (eGFR \<60 mL/min/1.73m2); iii. Increased serum creatinine (SCr) above reference range of the local laboratory; iv. Albuminuria (≥30 mg/g of creatinine or ≥30 mg/24h); v. Proteinuria (according to urinalysis results); p. Ophthalmology disorder defined by ≥1 of the following features - i. Vitreous body inclusions (opacification); ii. Glaucoma; iii. Pupillary disorders; iv. Vitrectomy 6. Absence of previously established ATTR PN diagnosis (ICD-10 code Е85.1, "Neuropathic hereditary familial amyloidosis"). Exclusion Criteria: 1. Participation in any interventional trial within the period since identification of bilateral involvement of carpal tunnel until the end of current study. The following criteria apply for non-inclusion of patients into the prospective part of the study: 2. Previously performed TTR genetic testing; 3. Verified B12 deficiency; 4. History of alcohol abuse according to the patient's medical record.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Research Site

    Arkhangelsk, Russia

  • Research Site

    Barnaul, Russia

  • Research Site

    Chelyabinsk, Russia

  • Research Site

    Irkutsk, Russia

  • Research Site

    Kazan', Russia

  • Research Site

    Krasnodar, Russia

  • Research Site

    Moscow, Russia

  • Research Site

    Nizhny Novgorod, Russia

  • Research Site

    Rostov-on-Don, Russia

  • Research Site

    Saint Petersburg, Russia

  • Research Site

    Samara, Russia

  • Research Site

    Ufa, Russia

  • Research Site

    Yekaterinburg, Russia

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