Muscular Dystrophy Trial, By Invitation NCT05854433 Sponsor: Wake Forest University Health Sciences Condition: Muscular Dystrophy
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Muscular Dystrophy Trial, By Invitation

NCT05854433
By Invitation Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

If you have Myotonic Dystrophy Type 2 (DM2):

  • You are between 30 and 65 years old
  • You have been diagnosed with DM1 or DM2 through genetic testing or by a doctor's assessment (if diagnosed by assessment only, a close blood relative must have had a positive genetic test)
  • You have symptoms or signs of weakness in the muscles closest to the center of your body (such as hips or shoulders)
  • You can walk on your own (using a cane or walking stick is fine)
  • You are willing and able to give your written agreement to take part in the study

If you have Myotonic Dystrophy Type 1 (DM1):

  • You are between 30 and 65 years old
  • You have been diagnosed with adult-onset DM1 through genetic testing or by a doctor's assessment (if diagnosed by assessment only, a close blood relative must have had a positive genetic test)
  • Your first symptoms began between the ages of 20 and 40
  • You have symptoms or signs of weakness in the muscles farther from the center of your body (such as hands or feet) and muscle stiffness
  • You can walk on your own (using a cane or walking stick is fine)
  • You are willing and able to give your written agreement to take part in the study

If you are a Healthy Volunteer:

  • You are between 30 and 65 years old
  • You can walk on your own
  • You are willing and able to give your written agreement to take part in the study

Who may not be able to join:

For people with DM1 specifically:

  • Your DM1 symptoms started before age 20 (known as congenital or childhood-onset DM1)
  • You have been diagnosed with dementia, epilepsy/seizures, stroke, multiple sclerosis, Parkinson's disease, or another condition that affects the brain or nervous system

For everyone (DM1, DM2, and healthy volunteers):

  • You have a pacemaker, defibrillator, or any metal implant in your body that is not safe to use inside an MRI scanner
  • You experience severe anxiety in enclosed spaces (claustrophobia)
  • You have been diagnosed with dementia, epilepsy/seizures, stroke, multiple sclerosis, Parkinson's disease, or another condition affecting the brain or nervous system
  • You are currently experiencing a significant mental health condition, or have issues with alcohol or substance use
  • You have a serious medical condition that would make MRI scanning or movement/strength testing unsafe
  • You are taking medications that cause significant drowsiness or affect your thinking, unless you have been on the same dose for at least 3 months before the study visit
  • You are currently pregnant
  • You weigh more than 400 pounds, as the MRI table may not be able to safely support you
  • You are unwilling or unable to give your written agreement to take part

If you take part in a spinal fluid (lumbar puncture) procedure:

  • You have taken blood-thinning medications (such as aspirin or similar drugs) within the last 7 days
  • You take anticoagulant medications such as warfarin (Coumadin)
  • You have a history of bleeding disorders
  • Your platelet count (a measure of blood clotting ability) was below 150,000 in the last 6 months
  • You have any hardware such as pins, screws, or rods in your lower back area

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
By Invitation
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
26 April 2023
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Measures of voxel-based brain morphometry; Fractional Anisotropy (FA); Radial Diffusivity (RD); Axial Diffusivity (AD)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov