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Parkinson DiseasePhase 2/3NCT03473522

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

A Phase 2/3 study testing tDCS and Exercise Therapy in people with Parkinson Disease, run by Alessandra Tanuri Magalhães at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
tDCS and Exercise Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteBrazil
Study dates
1 Feb 2018to 15 Jan 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Federal do Piauí

    Parnaíba, Piauí, 64202020

Other trials in Brazil

About this study

Official title: Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercises in Patients With Parkinson's Disease: Randomized Clinical Trial

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.

Read the detailed description

In this study, a randomized, double-blind, placebo-controlled experimental design will be used. The 30 participants will be randomized into two groups: (1) TDCs(anodal) + therapeutic exercises and (2) TDCs (sham) + therapeutic exercises. The treatment will be performed for 8 weeks, with three sessions per week, totaling 24 sessions of electrostimulation and therapeutic exercises. The primary variable (balance), secondary outcomes and other outcomes will be assessed before and after treatment. Follow-up of patients will be conducted at 8, 12 and 24 weeks after randomization. All evaluations will be performed by a single researcher who, like the patients, will not know which stimulation group will be participating. Patients diagnosed with Parkinson's who seek treatment at the Clinical School of Physiotherapy of the Federal University of Piauí will receive detailed instructions on the present study. The physiotherapist responsible for evaluations will explain the objectives of the study, possible treatments, eligibility criteria and potential risks arising from the application of brain stimulation and therapeutic exercises. Patients who agree to the conditions and sign the consent form may participate in the study. Participants who meet the eligibility criteria will be included in the study.

Being tested
tDCS, Exercise Therapy
Keywords
Transcranial Direct Current Stimulation, therapeutic exercises, Parkinson
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

    Also called non invasive brain stimulation

    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.

  • Exercise TherapyBehavioural

    Also called Physiotherapy

    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).

Study groups in NCT03473522
Study groupRoleWhat they receive
anodal tDCS +Exercise TherapyExperimentalAnodal 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,
Receives: Device: tDCS; Behavioral: Exercise Therapy
Sham tDCS+ Exercise TherapySham comparatorAnodal tDCS (2mA of intensity, for twenty minutes but thirdy seconds ON) over the motor cortex representation of trunk and lower limbs.
Receives: Device: tDCS; Behavioral: Exercise Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 weeks after randomization

Secondary outcomes (6)

  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.

    Measured: 3 and 6 months after randomization

  2. Change From Unified Parkinson´s Disease Rating Scale

    The Unified Parkinson's Disease Rating evaluate is composed of 42 questions, divided into 4 parts: motor symptoms; mental activity, behavior and mood; activities of daily living; complications of drug therapy. The mental activity, behavior and humor part counts of 4 questions being the score ranging from 0 to 4 totaling 16 points. The daily life activity part consists of 13 questions that range from 0 to 4 scores totaling 52 points. The motor symptoms part consists of 14 questions, in which some of them have to be applied independently for each member. Thus, there are 27 observations that vary the score from 0 to 4, totaling 108 points. Part of the complications of drug therapy consists of 23 questions in which 4 vary the score from 0 to 4 and 7 questions vary the score from 0 to 1 totaling 23 points. Thus, the scoring of this scale varies between 0 and 199 in that the higher the score the greater the impairment and the closer to zero the more tendency to normality

    Measured: 8 weeks, 3 and 6 months after randomization

  3. Change From Parkinson Disease Quality of Life

    Parkinson Disease Quality of Life is a questionnaire consists of 37 items, subdivided into four domains: parkinsonian symptoms (14 items), systemic symptoms (7 items), emotional function (7 items) social function (9 items). The score ranges from 1 (all time), 2 (almost always), 3 (sometimes), 4 (few times) and 5 (never). The score of each domain is determined by the average of the points of each domain. The sum of the average score of each domain is made and high scores refers to the individual's better perception regarding his or her quality of life.

    Measured: 8 weeks, 3 and 6 months after randomization

  4. Change in the perception scale of the overall effect

    Perception scale of the overall effect evaluates the level of perception of recovery of the patient in relation to the treatment comparing the beginning of the symptoms with the last days. It is a numerical scale of 11 points ranging from -5 to +5, being - 5: extremely worse; zero: no modification; and +5: fully recovered, with the highest score representing greater recovery

    Measured: 8 weeks, 3 and 6 months after randomization

  5. Maximal Isometric Voluntary Contraction

    Peak and average force (Kg or Newton) and time to peak (seconds) will be collected during the maximal Isometric contraction of knee extensor muscles.

    Measured: 8 weeks, 3 and 6 months after randomization

  6. Tampa Scale for Kinesiophobia (TSK)

    Irrational, and debilitating fear of movement and activity resulting from a feeling of vulnerability to painful injury or re-injury. Its a 17-item scale.

    Measured: 8 weeks, 3 and 6 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2018
  2. Study start1 Feb 2018
  3. Primary completion1 Dec 2019
  4. Study completion15 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, double-blind, sham-controlled, clinical trial involving two types of intervention: (1) Physical therapy + active tDCS; (2) Physical therapy + sham tDCS.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03473522
Sponsor's protocol ID
2.085.438
Status last verified
Apr 2021
First submitted
7 Feb 2018
Last updated
3 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing tDCS and Exercise Therapy in people with Parkinson Disease, run by Alessandra Tanuri Magalhães at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From balance (time frame: 8 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.

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