Effect of Sensory Electrical Stimulation on Resting Tremors in Patients with Parkinson's Disease

October 17, 2024 updated by: Mohamed Yassen, Cairo University

Parkinson's disease is one of the most prevalent motor disorders in the world . The disease is progressive and has no known treatment. In addition to a number of psychological and autonomic issues, the disease also cause movement abnormalities which are the most challenging problem because management is still limited by medication or traditional physiotherapy the most effective way to treat symptoms is through an interprofessional new modalities as sensory stimulation , this study will be the first of its type to measure the effect of sensory stimulation on static tremors. Also, this study is the first of its type to make a continues treatment protocol for patient with static tremors.

SO the purpose of these study will To investigate the effect of sensory electrical stimulation on resting tremors in Parkinson's patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Outpatient clinics, Faculty of Physical Therapy, Cairo University
        • Contact:
        • Contact:
          • Mohamed Yassin, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 45 and 60
  • Diagnosed with idiopathic Parkinson's disease with Magnetic resonance imaging of the brain
  • All the patients will have mild to moderate symptoms based on (the Unified Parkinson's Disease Rating Scale UPDRS) ≥ 3
  • Static tremors have been present at the hand and wrist
  • Absence of other disorders that cause similar symptoms like dystonia

Exclusion Criteria:

  • History of hand trauma causes stiffness
  • Presence of other neurological problems interferes with diagnosis as hemiplegic stroke
  • Secondary parkinsonism (drug-induced or vascular ) which has very low tremor magnitude which can not be detected The patient has a severe visual problem that does not allow following the instructions.
  • The patient educational level does not allow for following the instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group
traditional treatment of hand tremors
Other: traditional exercises
strengthening exercise for the shoulder muscles( shoulder extensors, shoulder retractors from prone position and shoulder external rotation exercise for 3 sets 10 repetition , weight bearing exercise on the hand from quadruped position and sitting position and strengthening exercise on the intrinsic muscles of the hand
Experimental: study group
traditional treatment in addition to sensory electrical stimulation
Other: traditional exercises
strengthening exercise for the shoulder muscles( shoulder extensors, shoulder retractors from prone position and shoulder external rotation exercise for 3 sets 10 repetition , weight bearing exercise on the hand from quadruped position and sitting position and strengthening exercise on the intrinsic muscles of the hand
Other: sensory electrical stimulation
The stimulated muscles included the flexor carpi radialis (FCR), extensor carpi radialis (ECR), and flexor carpi ulnaris (FCU). Rectangular surface electrodes (Ag/AgCl; 50mm _ 50mm size) were attached on the motor point of each muscle, i.e., at four fingerbreadths from biceps tendon of FCR, at two fingerbreadths distal from lateral epicondyle for the ECR, at two fingerbreadths volar to ulna at the junction of the upper and middle thirds of the forearm for FCU.14 Portable stimulators will use with the following stimulation settings: constant current (0.2 mA step), 100 Hz stimulation frequency, biphasic pulse, and 300 _s pulsewidth.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
triaxial gyrosensor (accelerator)
Time Frame: 3 weeks
Three-dimensional angular motion will measured at the index finger of the more affected hand, by using triaxial gyrosensor (STM32L151, STMicroelectronics, ). The gyrosensor will embedded in an elastic band and attached on the dorsum of proximal phalanx
3 weeks
Fahn-tolosa- marin clinical rating scale
Time Frame: 3 weeks
Fahn_tolosa_marin clinical rating scale( FTM) is avalid scale for asses hand tremor, it consist of two items related to the hand , 1_trmors 2_hand writing The score is form 0 to 4 , 0 mean no tremors , 4 means severe tremors
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/005124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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