Effects of 10kHz High-frequency Alternating Current Transcutaneous Stimulation on Tremor in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Resting tremor
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Resting tremor
时间窗: 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).
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.
Kinetic tremor
时间窗: 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).
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.
Postural tremor
时间窗: 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).
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.
次要结局
- Blinding success(10 minutes after the end of the stimulation [at 30 minutes] (T3).)
- 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).)
- Adverse events(10 minutes after the end of the stimulation [at 30 minutes] (T3) and 24 hours after the stimulation (T4).)
- 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).)
- Subjective degree of improvement(10 minutes after the end of the stimulation [at 30 minutes] (T3).)