NCT03638531

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Nevada, Las Vegas · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Parkinson's disease (PD) is the second most common neurodegenerative disorder and affects approximately 1 million people in the United States with total annual costs approaching 11 billion dollars. Current medical and surgical treatment approaches for PD are either only mildly effective, expensive, or associated with a variety of side effects. Therefore, the development of practical and effective therapeutic adjuncts to current treatment approaches would have significant benefits. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate cortical excitability and improve motor function in healthy subjects, older adults, and in stroke. However, there are several crucial issues that currently prevents the determination of the viability of tDCS as an adjunct intervention in PD. For example, the magnitude to which tDCS may be able to improve long-term motor learning beyond what can be achieved by practice alone in PD is unknown. It is also unclear if short-term improvements in motor function induced by tDCS and measured in the OFF state in PD can be attained over the long-term in the ON state, which is necessary for real world application. In addition, it is uncertain if the effects of tDCS generalize to non-practiced tasks and to the ipsilateral, non-tDCS stimulated hand. Finally, the physiological mechanisms underlying any of these issues have not been identified because no long-term motor learning tDCS studies in PD to date have concurrently quantified behavioral, clinical, and physiological measures. The project will be a single-center, double-blind, randomized, sham-controlled, experimental design. PD patients will practice 2 motor tasks (practice tasks) with their right (primarily affected) hand in 9 practice sessions over a 2 week period in association with either tDCS or SHAM stimulation of the left (contralateral) motor cortex. In addition, 4 testing sessions will be performed and will include a Baseline test, an end of training test (EOT), a follow up test 2 weeks after the end of training (EOT+14), and a follow up test 4 weeks after the end of training (EOT+28). The primary outcome variables will be the force error in the first practice task (precision grip task; PGT) and the stroke amplitude, stroke variability, and writing speed in the second practice task (handwriting task; HWT). The secondary outcome variables the Unified Parkinson's Disease Rating Scale (UPDRS) Part 3, the Purdue Pegboard Test (PT), and the Jebsen Taylor Hand Function Test (JTT).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Anodal tDCS	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).
DEVICE	SHAM tDCS	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).

Timeline

• Start date: 2018-07-30
• Primary completion: 2020-06-30
• Completion: 2020-12-31
• First posted: 2018-08-20
• Last updated: 2018-10-19

Locations

1 site across 1 country: United States