Parkinson Disease
Conditions
Keywords
Parkinson's disease
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.
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.
Interventions
COMBINATION_PRODUCTHigh frequency repetitive transcranial magnetic stimulation
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.
COMBINATION_PRODUCTLow frequency repetitive transcranial magnetic stimulation
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.
COMBINATION_PRODUCTSham repetitive transcranial magnetic stimulation
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.
Sponsors
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Unified Parkinson's disease Rating Scale - Session III | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on cortical excitability level | 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). |
| Changes on quality of life | 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. |
| Changes on Patient Global Impression of Change Scale | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes on sleep quality | 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. |
| Changes on balance | 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. |
| Changes on cortical activity | 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 |
| Changes on functional mobility to sit-to-stand | 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. |
| Changes on functional mobility | 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. |
| Changes on Unified Parkinson's disease rating scale - session II | 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. |
Countries
Brazil
Contacts
Primary ContactKátia M Silva, PhD
Backup ContactLívia Shirahige, MSc
Outcome results
None listed