Clinical trial NCT04116216: rTMS on Motor Function of Parkinson's Disease Patients With Different Phenotypes
Official title: Effects of rTMS Associated to Physical Therapy on Motor Function of Parkinson's Disease Patients With Different Phenotypes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Unified Parkinson's disease Rating Scale - Session III
timeFrame: baseline, after 7 days, after 15 days
Secondary outcomes:
measure: Changes on cortical excitability level
timeFrame: baseline, after 7 days, after 15 days
measure: Changes on quality of life
timeFrame: baseline, after 15 days
measure: Changes on Patient Global Impression of Change Scale
timeFrame: after 15 days
Other outcomes:
measure: Changes on balance
timeFrame: baseline, after 15 days
measure: Changes on functional mobility to sit-to-stand
timeFrame: baseline, baseline, after 7 days, after 15 days
measure: Changes on functional mobility
timeFrame: baseline, baseline, after 7 days, after 15 days
measure: Changes on Unified Parkinson's disease rating scale - session II
timeFrame: baseline, baseline, after 7 days, after 15 days
measure: Changes on sleep quality
timeFrame: baseline, baseline, after 7 days, after 15 days
measure: Changes on cortical activity
timeFrame: baseline, baseline, after 7 days, after 15 days
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Kátia M Silva, PhD
role: STUDY_CHAIR
References: