Using electrical stimulation to manage tremors in Parkinson's and essential tremor patients
Sensory-specific Peripheral Stimulation for Tremor Management
NA · Shirley Ryan AbilityLab · NCT04501133
This study is testing whether electrical stimulation can help reduce tremors in people with Parkinson's disease and essential tremor.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04501133 on ClinicalTrials.gov |
What this trial studies
This study investigates how peripheral electrical stimulation (PES) can influence tremors in patients with Parkinson's disease and essential tremor. It involves both healthy participants and patients, utilizing techniques such as transcranial magnetic stimulation (TMS), high-density electromyography (HD-EMG), and functional MRI to assess the effects of PES on muscle activity and brain function. The study aims to characterize the neurophysiological mechanisms behind tremor modulation and evaluate the long-term effects of PES on tremor reduction. Participants will undergo various assessments to determine the efficacy of PES at different joint levels.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 diagnosed with moderate to severe essential tremor or Parkinson's disease.
Not a fit: Patients with a history of neurological disorders other than tremor or those with conditions affecting motor function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to significantly reduce tremors in patients with Parkinson's disease and essential tremor.
How similar studies have performed: While the use of peripheral electrical stimulation is being explored, this specific approach combining multiple neurophysiological assessments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Healthy Participants: * Age from 18 to 80 years * No history of a brain and/or skull lesion * Normal hearing and (corrected) vision * Able to understand and give informed consent * No neurological disorders, no tremor * Absence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis) * Able to understand and speak English Inclusion Criteria for Patients: * Age from 18 to 80 years * No prior history of skull lesions or craniotomy * Normal hearing and (corrected) vision * Able to understand and give informed consent * Diagnosis of ET (Tremor Research investigation Group criteria) or diagnosis of PD (UK PD Society Brain bank diagnostic criteria) by a physician * Tremor in at least an upper limb with pure flexion-extension wrist tremor with posture (ET) and rest (PD). * Tremor at least moderate-severe by clinician judgment and tremor scales (Fahn Tolosa Marin Tremor Rating Scale (TETRAS), Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)) * Absence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, moderate to severe dyskinesias in PD) * Stable medication doses for at least 30 days prior to study enrollment * Able to understand and speak English Exclusion Criteria for Healthy Participants: * Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps * Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye * Surgical clips in the head or previous neurosurgery * Any magnetic particles in the body * Cochlear implants * Prosthetic heart valves * Epilepsy or any other type of seizure history * Any neurological diagnoses or medications influencing brain function * History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae) * Known structural brain lesion * Significant other disease (heart disease, malignant tumors, mental disorders) * Significant claustrophobia; Ménière's disease * Pregnancy (ruled out by urine ß-HCG if answers to screening questions suggest that pregnancy is possible), breast feeding * Non prescribed drug use * History of current substance abuse (exception: current nicotine use is allowed) * Recreational marijuana * Tremor, parkinsonism; neurological diseases; medical (cardiological, renal, hepatic, oncological) or psychiatric disease that would interfere with study procedures for asES, HD-EMG, TMS, or EEG * Dementia; severe depression; or prior neurosurgical procedures * Failure to perform the behavioral tasks or neuropsychological evaluation tests * Prisoners Exclusion Criteria for Patients: * Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps * Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye * Surgical clips or shunts in the head * Any magnetic particles in the body * Cochlear implants * Prosthetic heart valves * Epilepsy or any other type of seizure history * Significant claustrophobia; Ménière's disease * Pregnancy, breast feeding * Medications increasing risk for seizures * History of current substance abuse (exception: current nicotine use is allowed) * Failure to perform tasks (e.g., follow instructions to stay still in the scanner) or fill in safety screening forms * Prisoners * Atypical or secondary parkinsonism * Co-existence of other neurological diseases * Mixed or complex tremors * Inability or unwillingness to discontinue medications for tremor on the day of study assessments * Medical (cardiological, renal, hepatic, oncological) or psychiatric disease that would interfere with study procedures for asES, HD-EMG, TMS, or EEG; dementia; severe depression; prior neurosurgical procedures
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Jose Pons, Ph.D — Shirley Ryan AbilityLab
- Study coordinator: Jose Pons, Ph.D
- Email: jpons@sralab.org
- Phone: 312-238-4549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson's Disease, Essential Tremor, Peripheral electrical stimulation, Transcranial magnetic stimulation, High-density electromyography, Electroencephalography, Magnetic resonance imaging