Ongoing Human Clinical Studies
Our laboratory is focused on developing treatments and improved assessment tools for the neuromuscular diseases. We have been involved in a number of clinical therapeutic trials in amyotrophic lateral sclerosis and in other multicenter studies developing improved technologies. We have a specific interest in tools that can help assess the effects of therapy, including quantitative ultrasound technologies and electrical impedance myography. Many of these tools are still being refined, and thus our research continues to be an iterative process in which early versions of engineering concepts are applied, data collected and analyzed, refinements made the testing repeated. Like all science, our process of discovery takes place in irregular patterns; many small steps before an unexpected greater leap occurs.
Here are some of the current projects which we have initiated or with which our laboratory has been deeply involved:
ElectricALS
Accepting Study Participants at Various Sites
In this multicenter cohort study, we are exploring the use of Electrical Impedance Myography via the Myolex mScan® device for monitoring the development of amyotrophic lateral sclerosis (ALS) symptoms. ALS is a neurological condition that affects muscle control, and tracking its progression is crucial for treatment and research purposes.
Currently, ALS progression is primarily monitored using the ALS Functional Rating Scale (ALSFRS-R), a subjective questionnaire that has notable limitations. As an alternative, the mScan EIM technology is a non-invasive and painless tool, that uses a weak electrical current to assess muscle health. This portable and user-friendly device not only offers an objective measure but also facilitates convenient at-home measurements.
This study will involve several major U.S. medical centers. For more information about the participating centers, please visit our listing at NCT06491732.
Peripheral Motor Dysfunction
Accepting Study Participants
In this observational study, we are evaluating three technologies as potential biomarkers for diagnosing and tracking neuromuscular disorders. These disorders often present with muscle weakness, atrophy, impaired motor function, numbness, and pain. While some biomarkers offer valuable muscle assessments, they often come with high costs, significant effort, or discomfort. Our goal is to identify technologies that can provide a comprehensive, cost-effective, and bedside assessment of muscle in various neuromuscular diseases. The three technologies being investigated here are:
- Electrical Impedance Myography (EIM): This is a painless and noninvasive technique where we pass a small electrical current between electrodes placed on the skin to characterize histological and structural features of the muscle.
- Myofiber Threshold Tracking (TT) Excitability Testing: This test checks how easily the muscle fibers can be activated. A tiny needle is used to give two small electrical pulses to a specific muscle point. The first pulse boosts the muscle's response, and the second one measures how much faster the muscle reacts. The stronger the response, the more excitable the muscle is.
- Muscle Ultrasound (US): This technology allows us to create a detailed 2D image of the muscle, helping us see the structure and any changes in the muscle or surrounding tissue.
All three measurements will be taken on two muscles in the arm and leg of patients with neuromuscular conditions, as well as in healthy participants.
This study is currently enrolling! Interested? Visit our Participate in a Study page.
ENCOMPASS
Enrollment Opens Soon
In this interventional study, we are testing the effects of dry-needling treatments on trigger points associated with myofascial pain syndrome using three technologies. Muscle trigger points, a common feature of myofascial pain syndrome, are palpable nodules within tense bands of muscle fibers; trigger points can be painful to the touch or may spontaneously become painful. Currently, there are no standard and objective criteria to diagnose trigger points or monitor their progression and improvement with treatments such as dry needling. The three technologies being investigated here are:
- Electrical Impedance Myography (EIM): This is a painless and noninvasive technique where we pass a small electrical current between electrodes placed on the skin to characterize histological and structural features of the muscle.
- Myofiber Threshold Tracking (TT) Excitability Testing: This test checks how easily the muscle fibers can be activated. A tiny needle is used to give two small electrical pulses to a specific muscle point. The first pulse boosts the muscle's response, and the second one measures how much faster the muscle reacts. The stronger the response, the more excitable the muscle is.
- Muscle Ultrasound (US): This technology allows us to create a detailed 2D image of the muscle, helping us see the structure and any changes in the muscle or surrounding tissue.
All three measurements will be used on the trapezius muscle (the muscle that extends over the back of the neck and shoulders) before a dry needling treatment in patients with trigger points as well as healthy participants; then, all measurements will be repeated after 14 days to monitor pain relief and changes in the muscle.
Read more about the previous study on clinicaltrials.gov: NCT05793086
Publications on this project:
PUFIT
Closed to Data Analysis
In this pilot study, we are testing the use of an electrical impedance tomography (EIT) device as a potential new method of monitoring pulmonary function in patients with ALS.
Currently, clinicians monitor pulmonary function with “pulmonary function tests,” or PFTs, in which a patient must follow a lengthy procedure that involves breathing in specific patterns in various positions. This process is very laborious, especially for these patients whose respiratory function is declining.
Thoracic EIT is a noninvasive, technology in which a multi-electrode belt is placed across the chest, producing real-time impedance imaging of the chest during breathing. Both healthy participants and patients with ALS were asked to perform a standard PFT procedure while wearing the electrode belt, allowing us to compare the EIT data during a PFT to the standard PFT data and look for correlations.
Read more on clinicaltrials.gov: NCT05238038
Publications on this project:
BEXIT
Closed
The objective of this observational study was to learn if ultrasound-enhanced electrical impedance tomography (US-EIT) can distinguish muscle of healthy individual and patients with myopathy.
Diagnostic modalities for muscle disorders include electromyography and biopsy. While valuable, the approaches are quite invasive and not well suited for surveillance. In EIT, weak electrical currents are applied through electrodes positioned over the skin; resultant surface voltages are translated into cross-sectional images that show how impedance is distributed throughout a region of interest. These impedance maps can be numerically transformed to evaluate characteristics included conductivity, permittivity, and phase. In this ongoing study, we are evaluating a combined US-EIT system that simultaneously collects ultrasound images and impedance data.
Using a standard ultrasound transducer covered by a specialized casing with imbedded electrodes, measurements were obtained from deltoid, medial gastrocnemius, and tibialis anterior in healthy individuals and myopathy patients. Computerized three-dimensional reconstruction techniques and finite element modeling were used to determine and compare the EIT values for the two groups.
Read more on clinicaltrials.gov: NCT05238038
Industry-sponsored clinical trials
HEALEY ALS Platform Trial
The HEALEY ALS Platform Trial is a Phase 2/3 perpetual adaptive trial testing multiple experimental therapeutics for ALS. Enrollment for regimens A-G has now been completed, and as new study drugs become available, more regimens will be added to this trial.
Learn more about this trial here.
HARBOR Clinical Trial
The global Phase 3 HARBOR™ trial is a randomized, placebo-controlled, double-blind study evaluating del-desiran in people living with myotonic dystrophy type 1 (DM1). This study is actively recruiting; if you are interested in participating, please contact research coordinators Teresa Capella (tcapella@bidmc.harvard.edu) and Amy Lewandowski (alewand2@bidmc.harvard.edu).
Learn more about this trial here.