RecruitingNot ApplicableNCT04501133

Sensory-specific Peripheral Stimulation for Tremor Management


Sponsor

Shirley Ryan AbilityLab

Enrollment

180 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria17

  • 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

Exclusion Criteria38

  • 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
  • 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

Interventions

DEVICEPeripheral electrical stimulation

Electrical stimulation will be delivered to forearm muscles with an electrical stimulator (Digitimer Ltd., Hertfordshire, UK) so that they generate forces opposed to those arising from the tremorgenic input.

DEVICESingle pulse TMS

Single-pulse TMS (spTMS) will be delivered with a TMS stimulator (MagPro X100 w/ MagOption, MagVenture, Farum, Denmark) and a figure-of-eight TMS coil. An MRI-based TMS navigation system will be used to navigate the TMS coil (Localite, St Augustin, Germany).


Locations(1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States

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NCT04501133


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