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
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 parkinson-disease
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 4, 2019
CompletedStudy Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedOctober 4, 2019
October 1, 2019
1.2 years
September 23, 2019
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Unified Parkinson's disease Rating Scale - Session III
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 Outcomes (3)
Changes on cortical excitability level
baseline, after 7 days, after 15 days
Changes on quality of life
baseline, after 15 days
Changes on Patient Global Impression of Change Scale
after 15 days
Other Outcomes (6)
Changes on balance
baseline, after 15 days
Changes on functional mobility to sit-to-stand
baseline, baseline, after 7 days, after 15 days
Changes on functional mobility
baseline, baseline, after 7 days, after 15 days
- +3 more other outcomes
Study Arms (3)
High frequency rTMS + physical therapy
ACTIVE COMPARATORThe 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.
Low frequency rTMS + physical therapy
ACTIVE COMPARATORThe 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.
Sham rTMS + physical therapy
SHAM COMPARATORFor 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Applied Neuroscience Laboratory
Recife, Pernambuco, 50670-901, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kátia M Silva, PhD
Universidade Federal de Pernambuco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
September 23, 2019
First Posted
October 4, 2019
Study Start
October 15, 2019
Primary Completion
December 30, 2020
Study Completion
April 30, 2021
Last Updated
October 4, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share