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NCT04501133Felfüggesztve

Sensory-specific Peripheral Stimulation for Tremor Management

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 14.

Megadott ok: Study pending of funding that could not be secured

Rövid összefoglaló (regiszter, angolul)

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).

Állapot (regiszter)
Felfüggesztve
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
180 (tervezett)
Első benyújtás
2020. júl. 21.
Kezdés
2020. szept. 1.
Elsődleges befejezés
2026. júl. 15.
Fő szponzor
Shirley Ryan AbilityLab
Betegségek
Parkinson-kór
NCT-szám
NCT04501133

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Korábbi kezelés

  • 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

Más betegség

  • 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

Egyéb

  • 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

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Shirley Ryan AbilityLabChicagoEgyesült ÁllamokIsmeretlen állapot

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