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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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High-frequency alternating current (HFAC) stimulation involves applying electrical stimulation with a frequency above 1 kilohertz (kHz) to peripheral nerves, inducing immediate, reversible nerve block without causing damage. Studies have shown that frequencies between 10 and 20 kHz reduce maximal isometric grip strength when applied transcutaneously over peripheral nerves, suggesting a partial block of A-alpha fibers, which may help reduce nerve hyperexcitability and motor activity. Tremor-related pathologies, influenced by abnormal muscle activity, significantly impact the quality of life of patients, particularly those with Parkinson's disease (PD), where tremor represents one of the most annoying and disabling symptoms since early stages of the disease.

For these reasons, tremor-related pathologies could benefit from HFAC stimulation. To our knowledge, no studies have applied HFAC stimulation in patients with PD. The main objective of this study is to compare the effectiveness of sham stimulation and real stimulation (10kHz) for tremor \[rest tremor, postural tremor, kinetic tremor\] in people with PD. Secondary objectives include analyzing the effectiveness of stimulation for fine motor skills and maximal isometric grip strength in people with PD, as well as documenting adverse events and evaluating blinding success.

A double-blind, randomized, crossover-design study will be conducted at the University of Castilla-La Mancha. Two interventions will be performed in people with Parkinson's Disease during "Off" state, randomizing the order: Intervention A: 10kHz stimulation; Intervention B: sham electrical stimulation.

Conditions

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Parkinson's Disease and Parkinsonism Nerve Block Motor Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Two interventions will be performed:

* Intervention A: active stimulation (High-frequency current stimulation 10kHz).
* Intervention B: sham stimulation (simulated electrical stimulation).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Blinding of participants will be performed using the same equipment, electrodes, and placement for the real or sham stimulation treatments. In addition, both the participants and the outcome assessor will not have a view of the equipment screen.

Blinding of the outcome assessor will be performed using different team members for randomization of the interventions (Researcher 1), intervention (Researcher 2), evaluation (Researcher 3), and statistical analysis (Researcher 4). Randomization will be kept hidden from participants and research team members and only the researcher who will deliver the intervention (Researcher 2) will know the group assignment. Successful blinding of participants and evaluator will be analyzed.

Study Groups

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10kHz

Alternating current stimulation with a 10kHz frequency with a transcutaneous approach, 20 minutes for each intervention.

Group Type EXPERIMENTAL

Active group 10kHz

Intervention Type DEVICE

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.

Sham stimulation

Sham stimulation via transcutaneous approach will be delivered only for the first 30 seconds, following the same procedures as the 10kHz group.

Group Type SHAM_COMPARATOR

Sham intervention

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Treatment for tremor suppression (deep brain stimulation or medication within 5 hours).
* 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
* Comorbidities or conditions affecting tremor or coordination (cerebellar injury)

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No