Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247423
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-01-22
Brief Title:
High-frequency Alternating Current Stimulation for Tremor in Parkinsons Disease
Sponsor:
University of Castilla-La Mancha
Organization:
University of Castilla-La Mancha
Study Overview
Official Title:
Effects of 10kHz High-frequency Alternating Current Transcutaneous Stimulation on Tremor in People With Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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 90ยบ 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
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 90ยบ 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
Detailed Description:
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 Parkinsons 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 Parkinsons Disease during Off state randomizing the order Intervention A 10kHz stimulation Intervention B sham electrical stimulation
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 Parkinsons Disease during Off state randomizing the order Intervention A 10kHz stimulation Intervention B sham electrical stimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MCIN1013039501100011033 | OTHER | Ministery of science and innovation of Spain | None |