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

NCT06247423 | Completed

• 2 other identifiers: Parkinson-neuromodest-giftoMCIN/10.13039/501100011033
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

High-frequency alternating current stimulation; Parkinson's Disease; Tremor; Motor activity

Outcome Measures

Primary Outcomes (3)

• Resting tremor

  The tremor activity will be recorded using surface electromyography, linear and angular accelerations with the "Trigno® Wireless Biofeedback System (SP-W06-017 Delsys Inc. Massachusetts, USA)" device, placing one recording sensors on the muscle surface of the extensor digitorum communis and another on the abductor pollicis brevis muscles. All the tests will be measured with the more tremor-affected hand. Specifically, for resting tremor the patient will be at rest with their forearms supported, the wrist free, and the elbow flexed at 90 degrees for 1 minute and 30 seconds, while counting backward from 100 to 0 as quickly as possible. Only the last 30 seconds will be registered.

  Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).

• Postural tremor

  This outcome will be recorded using the "Trigno® Wireless Biofeedback System". For postural tremor, patients will maintain a posture with flexed shoulders at 90 degrees, extended and pronated forearms, with the wrist in a neutral flexion-extension position for 30 seconds.

  Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).

• Kinetic tremor

  This outcome will be recorded using the "Trigno® Wireless Biofeedback System". For kinetic tremor, patients will be asked to grasp a cup by the handle, always placed at the same distance on the table, bring it to their mouth, hold it in that position for 3 seconds, and then return it to its initial position. The test will be performed with the more tremor-affected hand.

  Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).

Secondary Outcomes (5)

• Fine motor skills-finger dexterity

  Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).

• Maximal isometric grip strength

  Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).

• Blinding success

  10 minutes after the end of the stimulation [at 30 minutes] (T3).

• Adverse events

  10 minutes after the end of the stimulation [at 30 minutes] (T3) and 24 hours after the stimulation (T4).

• Subjective degree of improvement

  10 minutes after the end of the stimulation [at 30 minutes] (T3).

Study Arms (2)

10kHz

EXPERIMENTAL

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

Device: Active group 10kHz

Sham stimulation

SHAM COMPARATOR

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

Device: Sham intervention

Interventions

Active group 10kHz 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.

10kHz

Sham intervention 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.

Sham stimulation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Ministry of Science and Innovation, Spain: collaborator
• Asociación Parkinson Toledo (CAP Toledo): collaborator

Study Sites (1)

Universidad de Castilla La Mancha

Toledo, Toledo, 45071, Spain

Location

Related Publications (3)

• Arruda BS, Reis C, Sermon JJ, Pogosyan A, Brown P, Cagnan H. Identifying and modulating distinct tremor states through peripheral nerve stimulation in Parkinsonian rest tremor. J Neuroeng Rehabil. 2021 Dec 25;18(1):179. doi: 10.1186/s12984-021-00973-6.

  PMID: 34953492 BACKGROUND

• Jitkritsadakul O, Thanawattano C, Anan C, Bhidayasiri R. Tremor's glove-an innovative electrical muscle stimulation therapy for intractable tremor in Parkinson's disease: A randomized sham-controlled trial. J Neurol Sci. 2017 Oct 15;381:331-340. doi: 10.1016/j.jns.2017.08.3246. Epub 2017 Aug 24.

  PMID: 28991711 BACKGROUND

• Contreras VT, Araque W, Delgado VS. Trypanosoma cruzi: metacyclogenesis in vitro--I. Changes in the properties of metacyclic trypomastigotes maintained in the laboratory by different methods. Mem Inst Oswaldo Cruz. 1994 Apr-Jun;89(2):253-9. doi: 10.1590/s0074-02761994000200026.

  PMID: 7885254 BACKGROUND

Related Links

• We used the references explained on this page to place the electromyography sensors.

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Motor Activity; Tremor

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julio Gómez-Soriano, PhD

  Toledo Physiotherapy Research Group (GIFTO). Castilla la Mancha University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two interventions will be performed: * Intervention A: active stimulation (High-frequency current stimulation 10kHz). * Intervention B: sham stimulation (simulated electrical stimulation).

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 7, 2024
• Study Start: February 2, 2024
• Primary Completion: June 28, 2024
• Study Completion: September 30, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)