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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

Must not have

Inability or unwillingness to discontinue medications for tremor on the day of study assessments

Any neurological diagnoses or medications influencing brain function

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

No Placebo-Only Group

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.

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.

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 below

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I am between 18 and 80 years old.

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My hearing and vision, with aids if necessary, are normal.

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I experience shaking in my arm, especially when I hold it out or at rest.

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I do not have any neurological disorders or conditions causing abnormal movements.

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I do not have any neurological disorders or tremors.

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I do not have any conditions like epilepsy or severe arthritis affecting my movement.

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I have never had a brain or skull lesion.

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I have been diagnosed with Essential Tremor or Parkinson's Disease by a doctor.

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I experience shaking in my arm, especially when I move or rest it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot or will not stop my tremor medications for assessments.

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I have a neurological condition or take medication that affects my brain function.

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My Parkinson's disease is not typical or is caused by another condition.

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I have surgical clips in my head or have had brain surgery before.

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I experience different types of shaking movements.

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I have a history of epilepsy or seizures.

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I am not taking any medications that increase my risk of seizures.

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I have had a serious head injury with long-term effects.

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I do not have major health issues like heart disease, cancer, or mental disorders.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and experiment a: baseline and through study completion, an average of 3 months. experiment b: baseline and through study completion, an average of 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

Changes in Amount of Motor Inhibition

Changes in cortico-muscular coherence in ET and/or PD participants

Changes in kinematics

+1 more

Secondary study objectives

Clinical motor score change

MRI/rs-fMRI connectivity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 18Eligibility criteria met