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NCT04501133Suspended

Sensory-specific Peripheral Stimulation for Tremor Management

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Reason given: Study pending of funding that could not be secured

Brief summary (registry, in English)

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).

Status (registry)
Suspended
Study type
Interventional
Enrollment
180 (estimated)
First submitted
21 Jul 2020
Start date
1 Sept 2020
Primary completion date
15 Jul 2026
Lead sponsor
Shirley Ryan AbilityLab
NCT number
NCT04501133

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Surgical clips in the head or previous neurosurgery
  • Cochlear implants
  • Any neurological diagnoses or medications influencing brain function
  • Non prescribed drug use
  • Dementia; severe depression; or prior neurosurgical procedures
  • Surgical clips or shunts in the head
  • Cochlear implants
  • 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

Other illness

  • Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
  • Prosthetic heart valves
  • Epilepsy or any other type of seizure history
  • History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
  • Significant other disease (heart disease, malignant tumors, mental disorders)
  • Significant claustrophobia; Ménière's disease
  • History of current substance abuse (exception: current nicotine use is allowed)
  • 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
  • Failure to perform the behavioral tasks or neuropsychological evaluation tests
  • Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
  • Prosthetic heart valves
  • Epilepsy or any other type of seizure history
  • Significant claustrophobia; Ménière's disease
  • 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
  • Co-existence of other neurological diseases

Other

  • Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
  • Any magnetic particles in the body
  • Known structural brain lesion
  • Pregnancy (ruled out by urine ß-HCG if answers to screening questions suggest that pregnancy is possible), breast feeding
  • Recreational marijuana
  • Prisoners
  • Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
  • Any magnetic particles in the body
  • Pregnancy, breast feeding
  • Prisoners
  • Atypical or secondary parkinsonism
  • Mixed or complex tremors

Who the study is looking for

  • 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
  • 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

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Shirley Ryan AbilityLabChicagoUnited StatesUnknown status

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