- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04116216
rTMS on Motor Function of Parkinson's Disease Patients With Different Phenotypes
Effects of rTMS Associated to Physical Therapy on Motor Function of Parkinson's Disease Patients With Different Phenotypes
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Kátia M Silva, PhD
- Phone Number: 8121268939
- Email: monte.silvakk@gmail.com
Study Contact Backup
- Name: Lívia Shirahige, MSc
- Phone Number: 8121268939
- Email: livia.shirahige@gmail.com
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50670-901
- Applied Neuroscience Laboratory
-
Contact:
- Kátia M Silva
- Phone Number: 8121268939
- Email: monte.silvakk@gmail.com
-
Contact:
- Email: monte.silvakk@gmail.com
-
Sub-Investigator:
- Rebeca Dias
-
Sub-Investigator:
- Brenda Leimig
-
Sub-Investigator:
- Thainã Moura
-
Sub-Investigator:
- Amanda Bezerra
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Study Chair: Kátia M Silva, PhD, Universidade Federal de Pernambuco
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMS_PD_phenotype
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on High frequency repetitive transcranial magnetic stimulation
-
Taipei Hospital, Ministry of Health and WelfareRecruitingDementia | Cognitive Impairment, MildTaiwan
-
VA Office of Research and DevelopmentRalph H. Johnson VA Medical CenterRecruiting
-
Universidade Federal de PernambucoCompleted
-
Kessler FoundationRecruitingSpinal Cord InjuriesUnited States
-
Universidade Federal de PernambucoUnknownSpinal Cord InjuriesBrazil
-
Cairo UniversityNot yet recruitingPatients With Multiple Sclerosis
-
University Hospital, CaenCompletedDepression | SchizophreniaFrance
-
Beth Israel Deaconess Medical CenterCompletedEpilepsy, Temporal LobeUnited States
-
University of RegensburgCompleted
-
University of FloridaMichael J. Fox Foundation for Parkinson's ResearchCompletedParkinson's DiseaseUnited States