NCT06247423Completed
High-frequency Alternating Current Stimulation for Tremor in Parkinson's Disease.
Effects of 10kHz High-frequency Alternating Current Transcutaneous Stimulation on Tremor in People With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 8 Nov 2024
Brief summary (registry, in English)
The goal of this randomized, double-blind, placebo-controlled, crossover study is to test the effectiveness of 10 kilohertz (kHz) high-frequency transcutaneous stimulation for tremor in people with Parkinson's disease. The main questions it aims to answer are: * Compare the effectiveness between sham stimulation and real stimulation (10kHz) for different types of tremors \[rest tremor, postural tremor, kinetic tremor\], fine motor skills, and maximal isometric handgrip strength. * Register adverse events, the blinding success of participants and evaluator, and subjective perception of tremor improvement. Participants will perform the following tasks in an "off" state (without levodopa and dopamine agonists medication). All of them were performed on the upper limb with more tremor. * Rest Tremor: Forearm on the armrest, count backward from 100 to 0 as fast as possible for 1 minute and 30 seconds. * Postural Tremor: Extend the arm parallel to the floor (90º shoulder flexion with the forearm extended) for 30 seconds. * Kinetic Tremor: Hold a cup by the handle, raise it close to the mouth for 3 seconds, then return to the initial position. * Fine Motor Skills: Complete the nine-hole peg test, placing pegs into holes as quickly as possible. * Handgrip Strength: Squeeze the device as strongly as possible for 3 seconds, then rest for 15 seconds.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 22 Jan 2024
- Start date
- 2 Feb 2024
- Primary completion date
- 28 Jun 2024
- Lead sponsor
- University of Castilla-La Mancha
- Diseases
- Parkinson disease
- NCT number
- NCT06247423
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 2 Feb 2024 to the primary completion date, 28 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment for tremor suppression (deep brain stimulation or medication within 5 hours).
Other illness
- Comorbidities or conditions affecting tremor or coordination (cerebellar injury)
Other
- Altered sensitivity in the intervention area
- Recent traumatism or surgeries which interfere with the measures
- Presence of pacemakers or other implanted electrical devices
- Tattoos or other external agents in the treatment area
Who the study is looking for
- Patients must have a confirmed diagnosis of Parkinson's Disease (PD) by a neurologist or specialist physician, specifically with tremor as defined by the consensual declaration of the "Movement Disorder Society".
- Must possess adequate cognitive capacity to perform the tests and understand all the procedure.
- Tolerance to the application of electrotherapy.
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de Castilla La Mancha Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.