Are you living with Parkinson’s symptoms?

If so, you may be eligible to take part in a clinical trial that will determine whether a non-invasive investigational device improves motor and non-motor symptoms of Parkinson’s.

Find a Participating Site Near You

Overview

Parkinson’s disease is an age-related degenerative brain condition that causes part of your brain to deteriorate. Parkinson’s is progressive meaning that symptoms change and tend to get worse over time. While Parkinson’s is mostly known for affecting movement, muscle control and balance, it also causes a wide range of non-motor symptoms that can impact your senses, thinking ability, mental health and more.



Parkinson's Symptoms

Motor Symptoms

The motor (movement-related) symptoms are widely recognized Parkinson’s disease symptoms because they are noticeable from the outside. These “motor” symptoms are what usually lead to the initial diagnosis, but motor symptoms are not the only burden of Parkinson’s.

Common Parkinson's motor symptoms can include:

  • Bradykinesia: slowness of movement
  • Tremors: shaking (usually of the arm, leg or chin) at rest
  • Rigidity: stiffness


Non-motor Symptoms

Non-motor (non-movement) symptoms are sometimes called the “invisible” symptoms of Parkinson’s because they often aren’t noticeable from the outside. However, for many people with Parkinson’s, these non-motor symptoms are as much, or more, of a burden than the motor symptoms.

Studies show that people living with Parkinson’s typically experience multiple different non-motor symptoms at any given time. Unfortunately, Parkinson's non-motor symptoms are not well treated by standard of care treatments for motor symptoms, and existing treatments for non-motor symptoms typically only address a single symptom. As a result, people with Parkinson’s must take many medications to address these non-motor symptoms.

Common Parkinson's non-motor symptoms can include:

  • Sleep issues: difficulty falling and staying asleep, restless legs or disordered sleep, like acting out dreams or experiencing vivid nightmares
  • Mood issues: anxiety (uncontrollable worry/nervousness for no clear reason), depression (sadness, loss of energy) or apathy (loss of interest in relationships or lack of motivation to start new activities)
  • Thinking or memory issues: struggling to focus on everyday tasks, forgetting names, not recalling something that recently happened or difficulty solving problems
  • Gastrointestinal issues: constipation, drooling or excess salivation and difficulty swallowing
  • Urinary incontinence or other issues: needing to use the restroom urgently or frequently
  • Sexual issues: erectile dysfunction in men or loss of libido in women
  • Fatigue or daytime sleepiness: physical or mental tiredness or excessive daytime sleepiness
  • Hallucinations or visual disturbances: seeing things that aren’t there or having false and often threatening beliefs
  • Impulse control and related disorders: such as increased gambling, buying, eating or sexual behaviors; routinely taking more anti-parkinsonian medications than prescribed
  • Feeling lightheaded or dizzy upon standing
  • Pain: muscle or bone pain, shooting pain, central pain (constant, dull, aching pain that affects most of the body), pain caused by involuntary movements, cramping

What is a Clinical Trial?

STEM-PD Clinical Trial Overview

Until now, Parkinson’s disease treatments mainly focused on helping motor symptoms or specific non-motor symptoms of Parkinson’s. The STEM-PD clinical trial is testing the ability of a non-invasive investigational medical device to help improve many non-motor symptoms as well as motor symptoms in Parkinson’s.

The purpose of the STEM-PD clinical trial is to understand how a non-invasive, home-use, neuromodulation investigational device affects adults diagnosed with Parkinson’s. A non-invasive device stays outside of the body, and neuromodulation means that the device stimulates activity in the brain.

The STEM-PD clinical trial does not require surgery and does not include investigational medicines.

Am I Eligible?

Am I Eligible for the STEM-PD clinical trial?

You may be a good candidate to participate in the STEM-PD trial if you:

  • Are 18 – 85 years old
  • Were diagnosed with Parkinson's disease one or more years ago
  • Are taking stable doses of anti-Parkinson's medications
  • Experience some limitations in your activities of daily living (e.g., writing, walking, bathing, dressing, eating, toileting, etc.)
  • Have at least two or more non-motor symptoms associated with Parkinson’s
  • Have a study partner such as a spouse, family member or friend who sees you more than one hour a day, three times per week and is willing to participate in the trial
  • Have access to and are comfortable using a smartphone to provide information to the study staff

*A participating site will ask you more questions to determine if you might be eligible.

Time Commitment

If you agree to take part in the STEM-PD trial and are eligible, your participation will last about one year and will include in-person visits, virtual visits as well as phone calls. Additionally, you will answer questions using a smartphone.

In this study, participants give themselves the treatments with the investigational device, which looks like a set of music headphones, at home twice a day, 20 minutes at a time. Each study treatment delivers a stimulation pattern.

During the first four months, you will be in the randomized clinical trial phase. You will be randomly assigned (like the flip of a coin) to one of two study treatment groups. The two groups will use the same device but will receive different stimulation patterns. You or your doctors will not know which group you are in.

In the second phase during the remaining eight months, everyone will receive a device programmed with the neurostimulation pattern reported to show benefit in a previous Parkinson’s clinical trial. This second phase includes two treatment periods and follow-up after you stop treatment with the investigational device.

Participation

To take part in this clinical study you will need to:

  • Complete the treatments two times a day in your home during the treatment periods
  • Recline during the treatment, but you can do other activities such as watch TV or read
  • Complete six in-person clinic visits
  • Complete seven virtual (video) calls with the study staff
  • Complete 26 phone calls with the study staff
  • Perform questionnaires and assessments at your home on a smartphone

Your study partner will need to:

  • Accompany you to all in-person and virtual visits
  • Answer questions related to your health and activities of daily living as necessary
  • Answer questions related to the impact of your Parkinson’s on their life


A map of participating clinical trial sites