Effects of tDCS Combined With Therapeutic Exercises in Patients With Parkinson's Disease.

NCT03473522 | Completed Phase 2 DMC

• 1 other identifier: 2.085.438
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Therapeutic exercises are widely employed in the attempt to delay or minimize disease progression, characterized by significant motor and sensory deficits. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (TDCs) as a complement to therapeutic exercises. However, few studies have investigated the effects of TDCs combined with therapeutic exercises in patients with Parkinson's disease. This study aims to investigate the effect of TDCs combined with therapeutic exercises in people with Parkinson's disease. Thirty patients will be randomized into two distinct groups to receive either TDCs(anodal) + therapeutic exercises or TDCs (sham) + therapeutic exercises for 24 sessions over a five-week period. The primary clinical outcome (balance) and secondary outcomes (functional capacity, quality of life and perception of overall effect) will be collected before treatment after two and five weeks at month 3 and month 6 after randomization. The data will be collected by a blind examiner to the treatment allocation.

Conditions

Parkinson Disease

Keywords

Transcranial Direct Current Stimulation; therapeutic exercises; Parkinson

Outcome Measures

Primary Outcomes (1)

• Change From balance

  Balance will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) and Mediolateral (ML) axes in centimeters. Other variables such as area (cm²), speed AP and ML(cm/s), frequency (Hz) and Entropy (no unit) will be derived from COP displacement.

  8 weeks after randomization

Secondary Outcomes (6)

• Change From balance

  3 and 6 months after randomization

• Change From Unified Parkinson´s Disease Rating Scale

  8 weeks, 3 and 6 months after randomization

• Change From Parkinson Disease Quality of Life

  8 weeks, 3 and 6 months after randomization

• Change in the perception scale of the overall effect

  8 weeks, 3 and 6 months after randomization

• Maximal Isometric Voluntary Contraction

  8 weeks, 3 and 6 months after randomization

Other Outcomes (1)

• Geriatric Depression Scale (GDS)

  8 weeks, 3 and 6 months after randomization

Study Arms (2)

anodal tDCS +Exercise Therapy

EXPERIMENTAL

Anodal tDCS (2mA of intensity, for twenty minutes) over the motor cortex representation of trunk and lower limbs. Immediately after tDCS application all the patients will participate in an exercise therapy protocol involving balance control, strength,

Device: tDCS; Behavioral: Exercise Therapy

Sham tDCS+ Exercise Therapy

SHAM COMPARATOR

Anodal tDCS (2mA of intensity, for twenty minutes but thirdy seconds ON) over the motor cortex representation of trunk and lower limbs.

Device: tDCS; Behavioral: Exercise Therapy

Interventions

tDCS DEVICE

Transcranial direct current stimulation is a modulation technique of neuronal excitability which has very promising results in Parkinson's disease. In addition to the possibility of increasing the excitability of areas to tDCS, it can also facilitate the execution of the exercises by increasing the excitability of the primary motor cortex and changing the recruitment strategies of the motor units.

Also known as: non invasive brain stimulation

Sham tDCS+ Exercise Therapy; anodal tDCS +Exercise Therapy

Exercise Therapy BEHAVIORAL

Therapeutic exercises will be based on the literature (O'Sullivan and Schmitz 2004, Klamroth et al 2016, Reynolds et al., 2016, Pérez et al 2016, Smania et al., 2010, Pastor et al., 1993, Traub et al., 1980, Schoneburg et al., 2013) Each session will be divided into warm-up exercises; balance and relaxation, with a duration of 50 minutes and a frequency of 3 times a week. Training progresses and intensifies every two weeks. The subjects will perform five repeated movements of each exercise, evolving according to the condition of each patient (according to the Hoehn and Yahr staging scale).

Also known as: Physiotherapy

Sham tDCS+ Exercise Therapy; anodal tDCS +Exercise Therapy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• medical diagnosis of idiopathic Parkinson's disease present for at least 12 months,
• spontaneous demand for treatment,
• in clinical follow-up and pharmacological treatment by a responsible physician,
• Parkinson's classification of 1.5-3 according to the Hoehn and Yahr scale,
• absence of cardiovascular diseases and musculoskeletal,
• signing of the free and informed consent form.

You may not qualify if:

• Use any associated orthopedic device to aid gait or balance control,
• signs of severe dementia (evaluated by the Mini-Mental State Examination - MMSE),
• diagnosis of other neurological disorders (including those of central and peripheral nature)
• previous treatment with tDCS,
• medical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants)
• the use of pacemakers or other implanted devices.

Sponsors & Collaborators

• Alessandra Tanuri Magalhães: lead
• Foundation for Research Support of the State of Piauí: collaborator

Study Sites (1)

Universidade Federal do Piauí

Parnaíba, Piauí, 64202020, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation; Exercise Therapy; 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; Aftercare; Continuity of Patient Care; Patient Care

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor of Physical Therapy Department

Model Details: A randomized, double-blind, sham-controlled, clinical trial involving two types of intervention: (1) Physical therapy + active tDCS; (2) Physical therapy + sham tDCS.

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: March 22, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 15, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)