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

NCT02205216 | Unknown DMC

• 1 other identifier: VD226/14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Parkinson Disease

Keywords

tDCS; FOG; Freezing of Gait; Parkinson; Rehabilitation

Outcome Measures

Primary Outcomes (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.

  from baseline to one month follow-up

Secondary Outcomes (6)

• New Freezing of Gait Questionnaire (N-FOGQ)

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

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

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

• 39-Item Parkinson's Disease Questionnaire (PDQ-39)

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

• Beck Depression Inventory (BDI)

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

• 10 Meter Walk Test (10MWT)

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

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Active tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.

Device: Active tDCS; Behavioral: Rehabilitation Therapy

Sham tDCS

SHAM COMPARATOR

Sham tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.

Device: Sham tDCS; Behavioral: Rehabilitation Therapy

Interventions

Active tDCS DEVICE

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

Active tDCS

Sham tDCS DEVICE

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.

Sham tDCS

Rehabilitation Therapy BEHAVIORAL

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).

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Rehabilitation

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)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David Benninger, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: July 31, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2017
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

CH (1)