Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effects of Transcranial Direct Current Stimulation Associated With Physical Therapy on Motor Rehabilitation in Parkinson´s Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877148
• Other study ID #: Parkinson_tDCS_rehabilitation
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2013
• Last updated: May 14, 2015
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The present study aims to investigate the effect of transcranial direct current stimulation (tDCS) associated with physiotherapy in parkinson´s rehabilitation. Previous studies showed that tDCS could reduce the bradykinesia, one of the symptom of Parkinson disease. In this way, this study will combine tDCS with physiotherapy in order to enhance the motor rehabilitation and the quality of life.

Description:

12 patients were participated of this study.After screening to check the eligibility criteria and giving informed consent, they were randomized in two groups. All patients were submitted to a 10 therapeutic sessions that occurred 3 times per week.

Before, immediately after and 1 month after the last session patients were submitted to an evaluation with the follow tests: Unified Parkinson´s Disease Rating Scale(UPDRS), Jebsen Taylor Test (JTT) and Parkinson's Disease Quality of Life (PDQL). Furthermore, before and after each session the patients were submitted to transcranial magnetic stimulation (TMS) to evaluate cortical excitability through motor threshold and motor evoked potential.

In experimental sessions, the subjects always received physiotherapy with conventional techniques, the protocol followed the clinical practice guideline for physical therapy in Parkinson disease with the Royal Dutch Society Therapy. During tDCS protocol the patients seated in a comfortable chair with head and arm rests. Continuous current was applied using a pair of saline-soaked surface sponge electrodes (surface 35 cm2), the anode electrode was placed over the primary motor cortex and cathode above contralateral orbit. tDCS was applied of twice stimulation of 13 minutes with 20 minutes of interval between them and a current strength of 1mA. Sham tDCS was applied by current flow of 30s.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

Parkinson disease comproved by a neurologist Regular treatment with dopamine or other drugs against parkinson -

Exclusion Criteria:

pregnant history of convulsion metal implant in the region of skull or face change in medication during the study realize other physical therapy in the same time of the study previous surgery for parkinson disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• tDCS
tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability.

Behavioral:
• Physiotherapy
Physiotherapy protocol followed the guidelines outlined in clinical practice guideline for physical therapy in Parkinson disease of the Royal Dutch society for physical therapy (Keus, 2007). This guideline proposes some objectives for motor rehabilitation in patients with PD, such as: flexibility, strength, coordination, balance, posture and gait. The difficulty of exercises ranged according with Hoehn and Yahr (HY) staging scale. In this way, each stage of HY had a specific physical therapy protocol following the guideline.

Locations

Country	Name	City	State
Brazil	Applied Neuroscience Laboratory	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Parkinson Disease Quality of Life - PDQL	Parkinson disease quality of life is the sum of 37 questions, total score ranging from 0 (best possible outcome) to 185 (worst possible outcome)", as accurate and appropriate	at baseline, after 1 month	Yes
Other	Change From Jebsen-Taylor Hand Function Test - Jebsen Test	The Jebsen-Taylor Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living. Seven subtests are performed on both non-dominant and dominant hand: 1. Writing a 24-letter, 3rd grade reading difficulty sentence 2... Total score = sum of times for each subtests. Shorted times are indicative of better hand function	At baseline, after 1 month	Yes
Primary	Change From Unified Parkinson´s Disease Rating Scale - UPDRS	Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome)", as accurate and appropriate	At baseline, after 1 month	Yes
Secondary	Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation		per sesssion: at baseline and after physical therapy	Yes