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

NCT ID: NCT02205216

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS

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

Group Type: ACTIVE_COMPARATOR

Active tDCS

Intervention Type: DEVICE

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

Rehabilitation Therapy

Intervention Type: 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).

Sham tDCS

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

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: 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.

Rehabilitation Therapy

Intervention Type: 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).

Interventions

Active tDCS

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

Intervention Type: DEVICE

Sham tDCS

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.

Intervention Type: DEVICE

Rehabilitation Therapy

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

David Benninger, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Benninger, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

David Benninger, MD

Role: primary

david.benninger@chuv.ch

+41 21 314 95 83

Other Identifiers

VD226/14

Identifier Type: -

Identifier Source: org_study_id