Efficacy of Repetitive Trans-spinal Magnetic Stimulation on Axial Motor Symptoms in PD (rTSMS)

December 25, 2023 updated by: Eman M. Khedr, Assiut University

The Use of Non-invasive Trans-spinal Magnetic Stimulation to Enhance the Efficacy of Trans-cranial Magnetic Stimulation in Advanced PD With Axial Motor Symptoms: Double Blinded Randomized Clinical Trial

The purpose of this randomized trial was to evaluate the efficacy of repeated sessions of trans-spinal magnetic stimulation on gait abnormality, and posture abnormalities in patients with idiopathic Parkinson's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease is the second most common age-related neurodegenerative disease after Alzheimer's disease[1], patients with advanced Parkinson's disease (PD) often present with axial symptoms, including abnormal posture, postural instability, and gait disorder [2]. These axial symptoms are the main factors that reduce the activities of daily living (ADL) and quality of life (QOL) of PD patients. Gait disorders are among the most prevalent problems in the advanced phase of Parkinson's disease (PD) and are relatively resistant to dopaminergic treatment. Freezing of gait (FoG) affects 7% of patients in early PD and reaches 60% in advanced stages [3]. Patients with PD also suffer from pain significantly more frequently than normal subjects. Low back pain and leg pain are the most commonly experienced pain symptoms in PD patients. One of the reasons is considered to be the decreased threshold of pain due to abnormality of the dopaminergic system in the basal ganglia of PD patients [3.4]. Administration of anti-parkinsonian medication or Deep brain stimulation results in increased pain thresholds. Treatment by medication or DBS is often ineffective for low back pain caused by postural deformity and is also ineffective for radicular or peripheral neuropathic. Because pain is an important factor that reduces the ADL and QOL of patients, the establishment of new and effective therapy is essential [5.6]. A positive effect of epidural spinal cord stimulation (SCS) on locomotive activity has been reported in animal models and small cohorts of PD patients and seems to be promising.[7] Transcutaneous SCS is an emerging method that activates similar target neural structures noninvasively and has recently been explored for the treatment of spasticity after spinal cord injury.[8] Here, the investigators will assess the safety and efficacy of transcutaneous magnetic SCS on freezing of gait (FoG) and other motor symptoms in a cohort of PD patients.

The investigators will be going to carry out a double-blinded randomized, case-controlled study on 42 patients who will be randomly chosen and categorize them into 2 groups, 21 patients each. The 1st group will receive real transcranial magnetic stimulation applied over each hand area High frequency 20 HZ, 80% of the motor threshold of hand, 10 sec for each train, 20 train with a total of 2000 pulses for each side plus transcutaneous spinal cord stimulation (over mid-dorsal vertebrae (thoracic 6) high frequency 10 HZ, 80% of the motor threshold of leg area10 sec for each train, 10 trains with total 1000 pulses for 10 consecutive days. The second group will receive the same protocol but the spinal stimulation will be sham stimulation as the coil lie perpendicular to the vertebral axis. Then the investigators will be going to compare the results of two groups at the end of sessions, one and two months after the last session to find out the efficacy of repetitive transcutaneous magnetic stimulation of the spinal cord on gait abnormalities and posture abnormalities, relief of pain, UPDRS, and as well as the quality of life in patients with idiopathic Parkinson's disease

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

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

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men or women of at least 40-80 years of age.
  2. Are reliable and willing to make themselves available for the duration of the study and are willing to follow up.
  3. Medically stable outpatients with a confirmed diagnosis of idiopathic PD according to United Kingdom Brain Bank Criteria
  4. Clear written informed consent from each participant in the trial.
  5. Patients after at least 6 h free of parkinsonian drugs (off-state).

Exclusion Criteria:

  1. Pregnants, breastfeeding, or willing to be pregnant during the study.
  2. Presence of a clinically significant medical or psychiatric condition that may increase the risk associated with the study
  3. Participation in any other type of medical research that may interfere with the interpretation of the study.
  4. Patients with severe motor disability (bed-ridden ) that may interfere with the study procedure.
  5. History of surgical or invasive intervention for Parkinson's disease.
  6. Patients with a history of seizures or epilepsy including history in a first-degree relative or patients on treatment that reduce the seizure threshold.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: real transcranial magnetic stimulation with sham transcutaneous magnetic stimulation of spinalcord
the patient will receive real rTMS 2000 pulses for each hand area 20Hz 80% of Motor threshold of the hand, 10 trains, each train 10 seconds plus sham stimulation 1000 pulses 10 Hz 80% of the motor threshold of the leg 10 trains, and each train 10 seconds over the mid-dorsal vertebrae for 10 consecutive days (5 sessions/week)
Device: non invasive repetitive magnetic stimulation (real Transcranial + sham trans-spinal )sham trans-spinal magnetic stimulation
sham trans-spinal magnetic stimulation
Active Comparator: real transcranial magnetic stimulation plus real transcutaneous magnetic stimulation of spinalcord
the patient will receive real rTMS 2000 pulses for each hand area 20Hz 80% of Motor threshold of the hand, 10 trains, each train 10 seconds over the hand area plus 1000 pulses 10 Hz 80% of the motor threshold of the leg 10 trains, and each train 10 seconds over the mid-cervical vertebrae for consecuative 10 days (5 days/week)
Device: non invasive repetitive magnetic stimulation (real Transcranial + real trans-spinal )
repetitive transcranial magnetic stimulation and trans-spinal magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on Freezing of gait Questionnaire
Time Frame: 2 months after the end of sessions
Score on Freezing of gait Questionnaire
2 months after the end of sessions
Time taken for Primed up-and-go
Time Frame: 2 months after the end of sessions
Time taken for Primed up-and-go
2 months after the end of sessions
Time taken for 10m walk
Time Frame: 2 months after the end of sessions
Time taken for 10m walk
2 months after the end of sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on MDS-UPDRS
Time Frame: 2 months after the end of sessions
Score on MDS-UPDRS
2 months after the end of sessions
Score on PDQ-39
Time Frame: 2 months after the end of sessions
Score on PDQ-39
2 months after the end of sessions

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2023

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

December 26, 2021

First Submitted That Met QC Criteria

February 27, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 25, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rTSMS in Parkinson's disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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