Long- Term Transcranial Direct Current Stimulation in Parkinson's Disease

NCT03638531 | Unknown Phase 2 DMC

• 1 other identifier: 1002548
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed research is to determine the influence of transcranial direct current stimulation (tDCS) on long-term motor learning, transfer of motor learning, and cortical function in Parkinson's disease (PD). The project comprises a 2 week training study that will involve tDCS applied during two practice motor tasks with behavioral, clinical, and physiological evaluations at baseline as well as 1, 14 and 28 days following the 2 week training and stimulation period. The findings of the proposed studies should have significant clinical significance and applications to comprehensive intervention therapy development in the treatment of PD.

Conditions

Parkinson Disease

Keywords

tDCS; cortical excitability; motor cortex; motor learning; handwriting; micrographia

Outcome Measures

Primary Outcomes (2)

• Force error in the precision grip task

  Changes in force error after the two week intervention

  Baseline, 1 day post, 2 weeks post, 4 weeks post

• Handwriting task performance

  Changes in stroke amplitude, stroke variability, and writing speed after the two week intervention

  Baseline, 1 day post, 2 weeks post, 4 weeks post

Secondary Outcomes (3)

• Transfer of motor learning

  Baseline, 1 day post, 2 weeks post, 4 weeks post

• Transfer of motor learning

  Baseline, 1 day post, 2 weeks post, 4 weeks post

• Transfer of motor learning

  Baseline, 1 day post, 2 weeks post, 4 weeks post

Study Arms (2)

Anodal tDCS

EXPERIMENTAL

Anodal tDCS will be applied in nine experimental sessions over a 2-week period.

Device: Anodal tDCS

SHAM tDCS

SHAM COMPARATOR

SHAM tDCS will be applied in nine experimental sessions over a 2-week period.

Device: SHAM tDCS

Interventions

Anodal tDCS DEVICE

Anodal tDCS will be applied over the FDI muscle representational area of the motor cortex for 25 minutes in combination with the two motor tasks (precision grip task and handwriting task).

Anodal tDCS

SHAM tDCS DEVICE

SHAM tDCS will be applied over the FDI muscle representational area of the motor cortex for 25 minutes in combination with the two motor tasks (precision grip task and handwriting task).

SHAM tDCS

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent.
• A clinical diagnosis of idiopathic PD.
• A stable and optimal medical regimen of anti-parkinsonian drug therapy for the duration of the study.
• Modified Hoehn and Yahr stage between 1.0 and 3.0 in the OFF state.
• Right-hand dominant and primarily right-side affected to prevent confounds due to handedness and affected side.

You may not qualify if:

• An uncontrolled medical condition (i.e. hypertension, diabetes, etc).
• Evidence of secondary or atypical parkinsonism as suggested by:
• History of CVA's, exposure to toxins, neuroleptics or encephalitis.
• Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy or significant orthostatic hypertension.
• Metal in the skull or the eye, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, and metal fragments in the eye, as these may make TMS and tDCS unsafe.
• An uncertainty about the presence of metal objects in a subject's body exists.
• Hearing loss, have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures, have another neurological disorder other than a movement disorder, or have a head injury where they passed out for more than a few seconds.
• Pregnant or thought to be pregnant.
• Irrepressible dyskinesia or tremor to prevent the confound of excessive EMG during TMS testing at rest.
• Any other neurological disorders.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

Bigelow Health Sciences

Las Vegas, Nevada, 89154-3034, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

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

Study Officials

• Brach Poston, Ph.D.

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: July 30, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 19, 2018

Record last verified: 2018-10

Locations

US (1)