Recruitment

Recruitment Status
Enrolling by invitation

Summary

Conditions
  • Essential Tremor
  • Parkinson Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Randomized, crossover, double-blinded designMasking: Double (Participant, Outcomes Assessor)Masking Description: Double-blinded designPrimary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

Description

The study had three stages. In the first stage, a wide range of investigatory pulse shapes in a small number of patients. The effect of the pulses on the therapeutic window will be assessed. Stage 2 will perform a short-term chronic evaluation (30 minutes and if safe, 1 week) in a larger number of p...

The study had three stages. In the first stage, a wide range of investigatory pulse shapes in a small number of patients. The effect of the pulses on the therapeutic window will be assessed. Stage 2 will perform a short-term chronic evaluation (30 minutes and if safe, 1 week) in a larger number of patients. In Parkinson's disease (PD) patients (after 30 minutes): - MDS-UPDRS-III (Movement Disorders Society - Unified Parkinson's Disease Rating Scale, part III) In essential tremor (ET) patients (after 30 minutes): - FTM (Fahn Tolosa Marin Tremor Rating Scale) In PD patients (after one week): MDS-UPDRS-III PDQ-39 (Parkinson's disease questionnaire - 39 items) NMSS (Non-motor Symptoms Scale) In ET patients (after one week): FTM QUEST (Questionnaire for Quality of Life in Essential Tremor) MOCA (Montreal Cognitive Assessment) Stage 3 will then focus on long-term evaluation (upto 2 years). The same tests are used as after the one-week testing.

Tracking Information

NCT #
NCT04725045
Collaborators
Not Provided
Investigators
Principal Investigator: Myles Mc Laughlin, Prof. Dr. KU Leuven
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