High-frequency Alternating Current Stimulation for Tremor in Parkinson's Disease.

Summary

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.

Conditions

• Parkinson's Disease and Parkinsonism
• Nerve Block
• Motor Activity

Interventions

DEVICE

Active group 10kHz

For electrical stimulation in the active groups, unmodulated alternating currents with a symmetrical rectangular waveform of 10 kHz will be applied for 20 minutes. The current intensity shall be adjusted individually for each participant by increasing the current intensity until the participant reports a "strong but comfortable tingling" sensation just below the motor threshold. One electrode will be placed over the median and radial nerves, while the other over the radial nerve. The intensity of the current shall be adjusted every two minutes if the tingling sensation decreases. This protocol had been used in previous studies conducted by our research group.

DEVICE

Sham intervention

Sham electrical stimulation will be performed with the same equipment, time, and electrodes as in the active groups without the participants and the evaluator having a view of the device screen. The intensity of the current will be increased for 30 seconds until the sensory threshold ("strong but comfortable tingling sensation") will be reached and after that, the intensity will be reduced to 0 milliamperes (mA) with 30 seconds ramp down. Participants will not receive electrical current during the rest of the placebo intervention. This protocol was used in other studies with similar interventions to blind participants.

Sponsors & Collaborators

• Ministry of Science and Innovation, Spain

  collaborator OTHER_GOV

• Asociación Parkinson Toledo (CAP Toledo)

  collaborator UNKNOWN

• University of Castilla-La Mancha

  lead OTHER

Principal Investigators

• Julio Gómez-Soriano, PhD · Toledo Physiotherapy Research Group (GIFTO). Castilla la Mancha University.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-02

Primary Completion

2024-06-28

Completion

2024-09-30

Countries

• Spain

Study Locations