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

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

Sponsors

Lead sponsor: Universidade Federal de Pernambuco

Source Universidade Federal de Pernambuco
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.

Overall Status Not yet recruiting
Start Date October 15, 2019
Completion Date April 30, 2021
Primary Completion Date December 30, 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Unified Parkinson's disease Rating Scale - Session III baseline, after 7 days, after 15 days
Secondary Outcome
Measure Time Frame
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
Enrollment 30
Condition
Intervention

Intervention type: Combination Product

Intervention name: High frequency repetitive transcranial magnetic stimulation

Description: 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.

Arm group label: High frequency rTMS + physical therapy

Intervention type: Combination Product

Intervention name: Low frequency repetitive transcranial magnetic stimulation

Description: 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.

Arm group label: Low frequency rTMS + physical therapy

Intervention type: Combination Product

Intervention name: Sham repetitive transcranial magnetic stimulation

Description: 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.

Arm group label: Sham rTMS + physical therapy

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

Gender: All

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Kátia M Silva, PhD Study Chair Universidade Federal de Pernambuco
Overall Contact

Last name: Kátia M Silva, PhD

Phone: 8121268939

Email: [email protected]

Location
facility contact contact_backup investigator Applied Neuroscience Laboratory Kátia M Silva 8121268939 [email protected] Lívia Shirahige, MSc Sub-Investigator Rebeca Dias Sub-Investigator Rodrigo Brito Sub-Investigator Brenda Leimig Sub-Investigator Thainã Moura Sub-Investigator Amanda Bezerra Sub-Investigator
Location Countries

Brazil

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Universidade Federal de Pernambuco

Investigator full name: Kátia Monte-Silva

Investigator title: Clinical professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: High frequency rTMS + physical therapy

Arm group type: Active Comparator

Description: 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.

Arm group label: Low frequency rTMS + physical therapy

Arm group type: Active Comparator

Description: 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.

Arm group label: Sham rTMS + physical therapy

Arm group type: Sham Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov