rTMS on Motor Function of Parkinson's Disease Patients With Different Phenotypes

October 2, 2019 updated by: Kátia Monte-Silva, Universidade Federal de Pernambuco

Effects of rTMS Associated to Physical Therapy on Motor Function of Parkinson's Disease Patients With Different Phenotypes

In this study we wondered whether patients with different phenotypes of Parkinson's disease respond differently to the protocol of repetitive transcranial magnetic stimulation (rTMS) associated with physical therapy. Furthermore, the study aims to compare the effects of rTMS protocols (high and low frequency) associated with physical therapy in PD patients with different phenotypes regarding to motor performance; bradykinesia; functional mobility; balance; quality of life; perception of improvement.

Study Overview

Detailed Description

After given prior informed consent, volunteers will be classified and randomized using a website (randomization.com) by a non-involved researcher. At study beginning, volunteers will be evaluated through structured questionnaire. They will be submitted to the following evaluations: (i) Unified Parkinson's disease Rating Scale (UPDRS); (ii) Parkinson's disease Sleep Scale; (iii) Parkinson's disease questionnaire; (iv) Short version of Balance Evaluation Systems Test; (v) Timed up and go; (vi) 5-times sit to stand test; (iv) Patient Global Impression of Change Scale. The cortical activity of the patients will be assessed through electroencephalography and transcranial magnetic stimulation.

Treatment - Participants will be randomly allocated to one of the following experimental protocols: (i) real high frequency rTMS + physical therapy protocol; (ii) real low frequency rTMS + physical therapy protocol; (iii) rTMS sham + physiotherapeutic protocol. The sessions will be performed five times a week for two weeks. Individuals allocated to the high frequency rTMS group will be performed the following protocol: first the coil center will be positioned over Cz for the first 1000 pulses. Then the coil will be moved to C4 and C3, where 1000 pulses will be delivered to each hemisphere. The intensity will be set to 100% of the motor threshold. The high frequency stimulation will be delivered at 10 Hz, offered in 20 50-pulse trains, with 30-second train intervals. The low frequency will be performed at 1 Hz. All groups will be treated with physical therapy immediately after rTMS.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

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

    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Applied Neuroscience Laboratory
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rebeca Dias
        • Sub-Investigator:
          • Brenda Leimig
        • Sub-Investigator:
          • Thainã Moura
        • Sub-Investigator:
          • Amanda Bezerra

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of PD provided by neurologist;
  • Aged 40 or over, of both gender;
  • Regular antiparkinsonian pharmacological treatment;
  • With staging from I to IV on the modified Hoehn & Yahr scale.

Exclusion Criteria:

  • Prior neurological diseases
  • Metal implant in the skull and face
  • Pacemaker
  • History of seizures
  • Epilepsy
  • Pregnancy
  • Other disorders that affect the performance of the tests and proposed intervention
  • Other osteomioarticular diseases in the lower limbs that interfere with performance and locomotion
  • Submitted to previous surgical intervention for PD

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: High frequency rTMS + physical therapy
The sessions will be performed five times a week for two weeks. The individuals will be performed the following protocol: first the coil center will be positioned over Cz for the first 1000 pulses. Then the coil will be moved to C4 and C3, where 1000 pulses will be delivered to each hemisphere. The intensity will be set to 100% of the motor threshold. The high frequency stimulation will be delivered at 10 Hz, offered in 20 50-pulse trains, with 30-second train intervals. After rTMS, patients will be submitted to 40 minutes of physical therapy protocol.
The sessions will be performed five times a week for two weeks. The individuals will be performed the following protocol: first the coil center will be positioned over Cz for the first 1000 pulses. Then the coil will be moved to C4 and C3, where 1000 pulses will be delivered to each hemisphere. The intensity will be set to 100% of the motor threshold. The high frequency stimulation will be delivered at 10 Hz, offered in 20 50-pulse trains, with 30-second train intervals. The low frequency will be performed at 1 Hz. After rTMS, patients will be submitted to 40 minutes of physical therapy protocol.
ACTIVE_COMPARATOR: Low frequency rTMS + physical therapy
The sessions will be performed five times a week for two weeks. The individuals will be performed the following protocol: first the coil center will be positioned over Cz for the first 1000 pulses. Then the coil will be moved to C4 and C3, where 1000 pulses will be delivered to each hemisphere. The intensity will be set to 100% of the motor threshold. The low frequency will be performed at 1 Hz. After rTMS, patients will be submitted to 40 minutes of physical therapy protocol.
The sessions will be performed five times a week for two weeks. The individuals will be performed the following protocol: first the coil center will be positioned over Cz for the first 1000 pulses. Then the coil will be moved to C4 and C3, where 1000 pulses will be delivered to each hemisphere. The intensity will be set to 100% of the motor threshold. The high frequency stimulation will be delivered at 10 Hz, offered in 20 50-pulse trains, with 30-second train intervals. The low frequency will be performed at 1 Hz. After rTMS, patients will be submitted to 40 minutes of physical therapy protocol.
SHAM_COMPARATOR: Sham rTMS + physical therapy
For sham stimulation, the stimulator positioned behind the patient will be turned off immediately after the determination of RMT, however, the coil will remain positioned over the patient's scalp (Cz, C3 and C4). A computer equipped with speakers will play an audio recording with the characteristic rTMS sound and no stimulation will be induced in the brain.
For sham stimulation, the stimulator positioned behind the patient will be turned off immediately after the determination of RMT, however, the coil will remain positioned over the patient's scalp (Cz, C3 and C4). A computer equipped with speakers will play an audio recording with the characteristic rTMS sound and no stimulation will be induced in the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Unified Parkinson's disease Rating Scale - Session III
Time Frame: baseline, after 7 days, after 15 days
In the present study we will analyze the UPDRS session III which comprises 14 items with a score of 0-4 each, from best to worst motor performance (SHULMAN et al., 2010). According to UPDRS scores, patients will be classified as: (i) tremor-dominant (TD) or (ii) with postural instability and difficulty in walking (PIGD).
baseline, after 7 days, after 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on cortical excitability level
Time Frame: baseline, after 7 days, after 15 days
it will be evaluated through single pulse transcranial magnetic stimulation. Initially, rest motor threshold (RMT) will be determined by finding the lowest stimulator output that elicit motor evoked potential (MEP) around 50 μV (TMS Motor Threshold Assessment Tool -MTAT 2.0 - USA For RMT measure, a figure-eight coil connected to the magnetic stimulator held manually at 45 degrees from the midline, will be placed over the primary motor cortex of most and less impaired hemisphere (C3 and C4 - 10/20 System).
baseline, after 7 days, after 15 days
Changes on quality of life
Time Frame: baseline, after 15 days
It will be evaluated through the score of each domain of Parkinson Disease Questionnaire (PDQ-39), a specific questionnaire for Parkinson's disease. It comprises 39 questions that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. Higher values represent a worse perception of quality of life.
baseline, after 15 days
Changes on Patient Global Impression of Change Scale
Time Frame: after 15 days
The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better".
after 15 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on balance
Time Frame: baseline, after 15 days
It will be evaluated by the short version of the Balance Evaluation Systems Test. This test is comprised of 14 full version items that assess the static and dynamic balance of individuals.
baseline, after 15 days
Changes on functional mobility to sit-to-stand
Time Frame: baseline, baseline, after 7 days, after 15 days
It will be assessed through the time of execution during 5-times sit to stand test. The mean of three trials will be recorded to measure fuctional mobility.
baseline, baseline, after 7 days, after 15 days
Changes on functional mobility
Time Frame: baseline, baseline, after 7 days, after 15 days
It will be assessed through the time of execution during timed up and go test. The mean of three trials will be recorded to measure fuctional mobility.
baseline, baseline, after 7 days, after 15 days
Changes on Unified Parkinson's disease rating scale - session II
Time Frame: baseline, baseline, after 7 days, after 15 days
The total score of this scale will also be used to assess the severity of the disease regarding the performance of daily life activities. The scale ranges a score from 0 to 4 for each question, from best to worst performance.
baseline, baseline, after 7 days, after 15 days
Changes on sleep quality
Time Frame: baseline, baseline, after 7 days, after 15 days
Through the Parkinson's Disease Sleep Scale (PDSS), consisting of 15 questions that assesses nocturnal disorders due to PD. Total scores less than 82 or less than five in each sub-item may be indicative of impairment in sleep quality.
baseline, baseline, after 7 days, after 15 days
Changes on cortical activity
Time Frame: baseline, baseline, after 7 days, after 15 days
The EEG electrodes will be positioned over the scalp of the patient, according to international marking system 10-20. During the acquisition of the electroencephalographic signal, a protocol (six minutes) of execution and motor imagination will be performed. The collected data will be further processed and analyzed using the MATLAB® software for Windows
baseline, baseline, after 7 days, after 15 days

Collaborators and Investigators

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

Investigators

  • Study Chair: Kátia M Silva, PhD, Universidade Federal de Pernambuco

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 (ANTICIPATED)

October 15, 2019

Primary Completion (ANTICIPATED)

December 30, 2020

Study Completion (ANTICIPATED)

April 30, 2021

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (ACTUAL)

October 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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