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NAC + Night Splints for Carpal Tunnel Syndrome (ACTS Trial)

Phase 4
Recruiting
Research Sponsored by Emily Krauss
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient has a confirmed diagnosis of mild to moderate idiopathic unilateral or bilateral CTS as determined by both clinical exam findings and electrodiagnostic nerve conduction studies (median nerve distal motor latency ≥ 4.3 milliseconds and/or median nerve sensory distal latency ≥ 3.5 milliseconds at the wrist) performed within the preceding year prior to enrollment
The patient must be ≥ 18 years of age.
Must not have
Any current medications which preclude use of NAC including antibiotics or nitroglycerin
Any previous carpal tunnel release procedure on the ipsilateral limb
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial is testing whether taking a supplement called N-acetylcysteine (NAC) along with wearing a wrist splint at night can help people with mild to moderate carpal tunnel syndrome. The goal is to see if this combination reduces symptoms like pain and numbness better than just using a wrist splint alone. NAC is known for its anti-inflammatory effects, which might help improve nerve function and reduce the need for surgery.

Who is the study for?
This trial is for adults over 18 with mild to moderate Carpal Tunnel Syndrome (CTS) confirmed by clinical exam and nerve studies, who have had symptoms for at least 6 weeks. It's not for those who've tried splinting or steroid injections in the past 6 months, are on certain medications like antibiotics or nitroglycerin, have severe CTS, previous carpal surgery, pregnancy-related CTS, breastfeeding, kidney stones, financial barriers to getting a night splint or allergies to NAC.
What is being tested?
The ACTS Trial is testing if taking an oral medication called N-acetylcysteine (NAC), known for its safety and anti-inflammatory properties can improve symptoms of CTS when used with night-splinting. Participants will either receive NAC or a placebo alongside standard night splinting for 8 weeks. The study aims to see if this combination reduces the need for surgery.
What are the potential side effects?
N-acetylcysteine (NAC) is generally very safe with few side effects reported. However, some individuals might experience mild adverse reactions such as nausea, vomiting, rash or headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with mild to moderate carpal tunnel syndrome in the last year.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on medications that interfere with NAC, like antibiotics or nitroglycerin.
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I have had carpal tunnel surgery on the same side as my current condition.
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I have severe carpal tunnel syndrome with constant hand pain or muscle weakness.
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I have had an injury to my neck or limb close to my body.
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I can't afford a night splint due to financial issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 8 weeks
Secondary study objectives
Change from baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 months
Number of participants who elect to have surgical carpal tunnel decompression after 6 months
Number of participants who elect to have surgical carpal tunnel decompression after 8 weeks

Side effects data

From 2024 Phase 2 trial • 13 Patients • NCT03499249
62%
GGT 400 IU/L >pre-KP value
46%
AST 400 IU/L >pre-KP value
31%
Loss of an IV
23%
Emesis with feeds
15%
Febrile illness
15%
Conjugated bilirubin 3 mg/dL >pre-KP value
8%
Tachycardia
8%
ALT 700 IU/L >pre-KP value
8%
INR >2.0
8%
Total bilirubin 5 mg/dL >pre-KP value
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-Acetylcysteine Treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NAC GroupExperimental Treatment2 Interventions
Participants in this group will given an N-acetylcysteine 500mg oral tablet daily in addition to wearing a standard carpal tunnel splint nightly (worn approximately 6-8 hours/day). Both interventions will take place concurrently for a total of 8 consecutive weeks.
Group II: Placebo GroupPlacebo Group1 Intervention
Participants in this group will be given a placebo table to be taken orally daily in addition to wearing a standard carpal tunnel splint nightly (worn approximately 6-8 hours/day). Both interventions will take place concurrently for a total of 8 consecutive weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Wrist Splint
2022
Completed Phase 4
~290
Cysteine
FDA approved

Find a Location

Who is running the clinical trial?

Emily KraussLead Sponsor
David TangLead Sponsor
Michael Bezuhly, MDStudy DirectorNSHA
1 Previous Clinical Trials
40 Total Patients Enrolled
~90 spots leftby Apr 2026
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