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

NCT01877148 | Completed Phase 2 Results DMC

• 1 other identifier: Parkinson_tDCS_rehabilitation
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson, rehabilitation, tDCS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation

  per sesssion: at baseline and after physical therapy

Other Outcomes (2)

• Change From Parkinson Disease Quality of Life - PDQL

  at baseline, after 1 month

• Change From Jebsen-Taylor Hand Function Test - Jebsen Test

  At baseline, after 1 month

Study Arms (2)

Physiotherapy + anodal tDCS

EXPERIMENTAL

The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.

Device: tDCS; Behavioral: Physiotherapy

Physiotherapy + sham tDCS

SHAM COMPARATOR

The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.

Device: tDCS; Behavioral: Physiotherapy

Interventions

tDCS DEVICE

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.

Also known as: non invasive brain stimulation

Physiotherapy + anodal tDCS; Physiotherapy + sham tDCS

Physiotherapy BEHAVIORAL

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.

Physiotherapy + anodal tDCS; Physiotherapy + sham tDCS

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Applied Neuroscience Laboratory

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation

Results Point of Contact

• Title: Kátia Monte-Silva
• Organization: Universidade Federal de Pernambuco

monte.silvakk@gmail.com

+ 55 (81) 2126-7579

Study Officials

• Kátia K Monte-Silva, PhD

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 13, 2013
• Study Start: January 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 15, 2015
• Results First Posted: May 15, 2015

Record last verified: 2013-06

Locations

BR (1)