Your session is about to expire
← Back to Search
Device
Sensory-Specific Peripheral Stimulation for Parkinson's Disease
N/A
Recruiting
Led By Jose Pons, Ph.D
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age from 18 to 80 years
Normal hearing and (corrected) vision
Timeline
Screening 3 weeks
Treatment Varies
Follow Up experiment a: baseline and through study completion, an average of 3 months. experiment b: baseline and through study completion, an average of 6 months.
Awards & highlights
Study Summary
This trial will investigate how electrical stimulation of the skin can help to ease tremor by studying brain activity in people with and without Parkinson's and essential tremor.
Who is the study for?
This trial is for adults aged 18-80 with moderate to severe tremor due to Parkinson's Disease or Essential Tremor, without other neurological disorders. Participants must have stable medication doses for at least 30 days and be able to understand English and consent. Exclusions include metal implants, pacemakers, substance abuse, pregnancy, mixed tremors, dementia, significant head trauma or diseases that could interfere with the study.Check my eligibility
What is being tested?
The study aims to explore how peripheral electrical stimulation (PES) affects brain signals that cause tremors in patients with Essential Tremor (ET) and Parkinson's Disease (PD). It involves non-invasive techniques like TMS and EEG along with MRI imaging in both healthy individuals and those affected by ET or PD.See study design
What are the potential side effects?
Potential side effects may include discomfort from electrical stimulation or TMS, temporary muscle twitching during PES application, headache after TMS sessions, skin irritation from electrode placement for HD-EMG recording. MRI-related side effects can include claustrophobia or discomfort lying still.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
My hearing and vision, with aids if necessary, are normal.
Select...
I experience shaking in my arm, especially when I hold it out or at rest.
Select...
I do not have any neurological disorders or conditions causing abnormal movements.
Select...
I do not have any neurological disorders or tremors.
Select...
I do not have any conditions like epilepsy or severe arthritis affecting my movement.
Select...
I have never had a brain or skull lesion.
Select...
I have been diagnosed with Essential Tremor or Parkinson's Disease by a doctor.
Select...
I experience shaking in my arm, especially when I move or rest it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ experiment a: baseline and through study completion, an average of 3 months. experiment b: baseline and through study completion, an average of 6 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~experiment a: baseline and through study completion, an average of 3 months. experiment b: baseline and through study completion, an average of 6 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Amount of Motor Inhibition
Changes in cortico-muscular coherence in ET and/or PD participants
Changes in kinematics
+1 moreSecondary outcome measures
Clinical motor score change
MRI/rs-fMRI connectivity
Trial Design
2Treatment groups
Experimental Treatment
Group I: PatientsExperimental Treatment2 Interventions
Participants with Parkinson's Disease or essential tremor will be scanned with MRI and undergo PES and/or single pulse TMS during several visits, each with different stimulation patterns, while HD-EMG and EEG are recorded.
Group II: Healthy ParticipantsExperimental Treatment2 Interventions
Healthy participants without motor disorders and medications influencing brain functions will be scanned with MRI and undergo PES and/or single pulse TMS during several visits, each with different stimulation patterns, while HD-EMG is recorded.
Find a Location
Who is running the clinical trial?
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
917,131 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
193 Previous Clinical Trials
16,785 Total Patients Enrolled
Jose Pons, Ph.DPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
1 Previous Clinical Trials
544 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medication doses have been the same for the last 30 days.You have a cochlear implant.I do not have any neurological, heart, kidney, liver, cancer, or mental health conditions that would affect the study.I understand the study and agree to participate.I cannot or will not stop my tremor medications for assessments.You have significant hand tremors, as determined by a doctor's assessment and specific tremor rating scales.I have a neurological condition or take medication that affects my brain function.I am between 18 and 80 years old.You have a known abnormality in your brain structure.My hearing and vision, with aids if necessary, are normal.I experience shaking in my arm, especially when I hold it out or at rest.I do not have any neurological disorders or conditions causing abnormal movements.My Parkinson's disease is not typical or is caused by another condition.I have surgical clips in my head or have had brain surgery before.You have a heart device like a pacemaker or wires, or a neurostimulator or implanted pump.You have any magnetic particles inside your body.You cannot complete the tasks or tests for behavior and thinking skills.You have a prosthetic heart valve.You have severe fear of enclosed spaces or have Ménière's disease.You have a history of using drugs or alcohol, except for nicotine.You have metal objects in your body or metallic particles in your eye.I experience different types of shaking movements.You have severe memory problems, very strong sadness, or have had surgery on your brain in the past.Using marijuana for fun or relaxation.You have other neurological diseases along with the condition being studied.Using drugs that were not prescribed by a doctor.I have a history of epilepsy or seizures.I am not taking any medications that increase my risk of seizures.I have had a serious head injury with long-term effects.I do not have any neurological disorders or tremors.I do not have any conditions like epilepsy or severe arthritis affecting my movement.I have never had a brain or skull lesion.You have shaking that is considered at least moderate to severe by a doctor and specific tremor assessment scales.I have been diagnosed with Essential Tremor or Parkinson's Disease by a doctor.I do not have major health issues like heart disease, cancer, or mental disorders.I experience shaking in my arm, especially when I move or rest it.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Participants
- Group 2: Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this research limited to those aged 18 or older?
"As the inclusion criteria for this clinical trial states, individuals aged 18 to 80 years old are eligible. Additionally, there is a separate cohort of 27 studies that are available to those under the legal age and another 521 trials accessible by patients 65 or older."
Answered by AI
How many participants are in the current clinical trial at its peak?
"Affirmative. In accordance with clinicaltrials.gov, this trial is actively enrolling participants since its launch on September 1st 2020 and latest update from July 13th 2022. The research team are aiming to recruit a hundred patients from one location."
Answered by AI
Would I qualify to participate in this clinical research?
"Currently, this medical study is looking for 100 participants aged between 18 and 80 that are afflicted with familial tremor. Those hoping to join must meet the following criteria: Age from 18 to 80 years; no prior brain or skull lesions; normal hearing and vision; diagnosed ET (Tremor Research Investigation Group Criteria) or PD (UK Parkinson’s Disease Society Brain Bank Diagnostic Criteria); moderate-severe tremors as judged by clinical scales such Fahn Tolosa Marin Tremor Rating Scale and Movement Disorder Society - Unified Parkinson's disease Rating Scale; absence of any neurological disorders causing abnormal movement in extremities e.g epilepsy"
Answered by AI
Is this research effort actively enrolling participants?
"Per clinicaltrials.gov, this research is presently recruiting subjects; the trial was first listed on September 1st 2020 and has been recently modified on July 13th 2022."
Answered by AI
Who else is applying?
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
My tremors are getting worse and affecting the quality of my life.
PatientReceived 1 prior treatment
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger