NCT04501133 Sensory-specific Peripheral Stimulation for Tremor Management
| NCT ID | NCT04501133 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2020-09-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to understand the neurophysiological mechanisms of peripheral electrical stimulation (PES) in modulating supraspinal tremorogenic input to motoneurons. For this purpose, the investigators will use transcutaneous PES, high-density electromyography (HD-EMG), transcranial magnetic stimulation (TMS), electroencephalography (EEG), magnetic resonance imaging (MRI), and neuromusculoskeletal modelling. This study will be carried out in both healthy participants and patients with essential tremor (ET) and Parkinson's disease (PD).
Eligibility 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
Contact & Investigator
Jose Pons, Ph.D
PRINCIPAL INVESTIGATOR
Shirley Ryan AbilityLab
Frequently Asked Questions
Who can join the NCT04501133 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04501133 currently recruiting?
Yes, NCT04501133 is actively recruiting participants. Contact the research team at jpons@sralab.org for enrollment information.
Where is the NCT04501133 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04501133 clinical trial?
NCT04501133 is sponsored by Shirley Ryan AbilityLab. The principal investigator is Jose Pons, Ph.D at Shirley Ryan AbilityLab. The trial plans to enroll 180 participants.
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