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Parkinson DiseaseNCT02205216

Can tDCS Enhance Efficacy of Rehabilitative Intervention for Freezing of Gait in Parkinson's Disease?

A study testing Active tDCS and Rehabilitation Therapy in people with Parkinson Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and responds often incompletely to conventional therapy. The pathogenesis remains largely unknown and therapeutic alternatives are needed. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Active tDCS and Rehabilitation Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSwitzerland
Study dates
Sep 2014to Aug 2017
Phase
Interventional
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • men and women aged 30 to 80 years with DOPA-responsive PD Hoehn and Yahr (HY) grade of 2 to 4 while "off"
  • must be on a regimen including levodopa
  • total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
  • Gait difficulties with Freezing of Gait as defined by MDS-UPDRS I score ≥ 2 in FOG
  • Optimal conventional PD medication for > 1 month prior to screening
  • scheduled for rehabilitative intervention for the treatment of freezing of gait

Who cannot join

  • significant concurrent medical or psychiatric disease
  • history of seizures and epilepsy
  • Dementia or other neurodegenerative disease (besides PD)
  • pallidotomy, implanted electrodes and generator for deep brain stimulation
  • pregnancy
  • surgically or traumatically implanted foreign bodies such as an implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tDCS.
Show all 12Show fewer
  • Study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
  • significant postural instability with daily falls, inability to walk the parcours or inability to walk 10 meters.
  • presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MOCA) <20 or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview).
  • presence of other co-morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
  • presence of clinically significant hallucinations
  • participation in any rehabilitation therapy for FOG within the last six months prior to screening

Trial locations and contacts

1 site in 1 country.

Switzerland1 site, 1 recruiting

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

    David Benninger, MD, +41 21 314 95 83, david.benninger@chuv.ch

    David Benninger, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: Can Transcranial Direct Stimulation Enhance the Efficacy of a Rehabilitative Intervention for the Treatment of Freezing of Gait in Parkinson's Disease? A Double Blind Randomized Controlled Study

Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and responds often incompletely to conventional therapy. The pathogenesis remains largely unknown and therapeutic alternatives are needed. Rehabilitative interventions that consist of learning cognitive strategies with sensory cueing to prevent and to overcome FOG represent the most efficacious intervention, but difficulties in learning and execution of these cognitive strategies are the main cause of failure. Transcranial direct current stimulation (tDCS) enhances motor task learning and execution in patients with PD and might enhance the efficacy of rehabilitative interventions.

This study intends to address the following question whether tDCS can enhance the efficacy of rehabilitative interventions in the treatment of freezing of gait in Parkinson's disease?

Being tested
Active tDCS, Sham tDCS, Rehabilitation Therapy
Keywords
tDCS, FOG, Freezing of Gait, Parkinson, Rehabilitation
Medical subject headings
Parkinson Disease

What participants receive

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

  • Active tDCSDevice

    anode over the motor and premotor cortex with cathodes placed over both mastoids. TDCS will be applied for 20 minutes at 2 mA.

  • Sham tDCSDevice

    anode and cathode placed 1 cm apart over the forehead and DC (1mA) applied for 1-2 min, short-circuited through the skin creating the same temporary "tingling" sensation without effects on the brain.

  • Rehabilitation TherapyBehavioural

    All patients will undergo a rehabilitation therapy intervention (2x a week for 4 weeks = 8 intervention sessions) with simultaneous sham or active tDCS. The trained physiotherapist will follow a standardized program with checklist. Each of the 8 training session will last approximately 45min. The rehabilitative interventions include:

    1. cognitive training: attentional strategies (mental counting, mental obstacle)
    2. transfer training: everyday activities
    3. motor training (walking) with sensory cueing (visual, acoustic, cane, ball) The rehabilitation therapy is divided into two sessions both including a 5 minutes warm-up and the learning of cueing and movement strategies based on different modalities (cognitive, visual, tactile and auditory).
Study groups in NCT02205216
Study groupRoleWhat they receive
Active tDCSActive comparatorActive tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
Receives: Device: Active tDCS; Behavioral: Rehabilitation Therapy
Sham tDCSSham comparatorSham tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
Receives: Device: Sham tDCS; Behavioral: Rehabilitation Therapy

What is being measured

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

  1. Walking parcours

    This standardized parcours, performed under guidance of a physiotherapist, includes real-life conditions which are known to precipitate freezing. Time needed to perform the parcours and number of FOG episodes will be assessed.

    Measured: from baseline to one month follow-up

Secondary outcomes (6)

  1. New Freezing of Gait Questionnaire (N-FOGQ)

    NFOG-Q is a widely used and validated questionnaire for quantifying FOG severity and frequency in the daily living

    Measured: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)

  2. Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Measured: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)

  3. 39-Item Parkinson's Disease Questionnaire (PDQ-39)

    Measured: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)

  4. Beck Depression Inventory (BDI)

    Measured: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)

  5. 10 Meter Walk Test (10MWT)

    10MWT measures the time taken and the number of steps needed to walk a 10-meter distance from a standing position. Gait testing includes three averaged trials.

    Measured: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)

  6. Timed Up & GO (TUG)

    TUG requires patients to get up of a standard armed-chair, to walk 3 meters away, to turn around a cone, to walk back and to sit down.

    Measured: from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)

Timeline

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

  1. First posted31 Jul 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionAug 2017 (estimated)

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 N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02205216
Sponsor's protocol ID
VD226/14
Status last verified
Jul 2015
First submitted
30 Jul 2014
Last updated
7 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Active tDCS and Rehabilitation Therapy in people with Parkinson Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

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 12 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: status not confirmed, as of the sponsor's last update on 7 Jul 2015. 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 Switzerland. 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.

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Walking parcours (time frame: from baseline to one month follow-up). 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 NCT02205216.

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 7 Jul 2015.

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