Transcranial Direct Current Stimulation (tDCS) to Improve Motor Function and Motor Fatigue in Parkinson's Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sanford Health
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Finger and Toe-Tapping on KinesiaOne Device
Study Overview
Brief Summary
The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left primary motor cortex (M1) will induce long-lasting effects in improving motor function and reducing motor fatigue and fatigability in PD patients.
Detailed Description
Parkinson's disease (PD) is the fastest growing and second most common neurodegenerative disease (after Alzheimer's disease) and affects approximately one million people in the United States. Impaired motor function is one of the cardinal features of PD. One of the diagnostic criteria for PD is bradykinesia (slowness of movement). In addition to bradykinesia, PD patients also suffer from increased motor fatigue and motor fatigability. In the body of fatigue research, the term "motor fatigue' usually refers to the general sensation of tiredness or of difficulty in initiating physical activity experienced over several days to weeks. This is often assessed by questionnaires completed by the subject. The term 'motor fatigability' refers to difficulty in maintaining physical activity at a desired level (Lou, 2009). This is often assessed quantitively in a laboratory setting. Motor impairments, motor fatigue, and motor fatigability affect quality of life in patients with Parkinson's disease.
Transcranial direct current stimulation (tDCS) is a noninvasive and safe brain stimulation technique that has been shown to be effective in improving motor function in subjects with Parkinson's disease. During tDCS, low-voltage, low amplitude current is passed through a pair of surface electrodes placed over the areas of brain of interest.
The specific aim of this study is to examine if atDCS to M1 at 2 milliamps (mA) for 20 minutes daily for 5 days will improve motor function and reduce motor fatigue and fatigability in PD patients. The study will examine if the effects may last for two weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
The participant and their care provider will be blinded as to which intervention is being used.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability)
- •Must be able to consent
Exclusion Criteria
- •Patients with dementia (MOCA < 21)
- •PD treatment using deep brain stimulation (DBS)
- •Diagnosis of psychosis
- •Diagnosis of multiple sclerosis
- •Diagnosis of stroke
- •Diagnosis of chronic obstructive pulmonary disease (COPD)
- •Diagnosis of congestive heart failure (CHF)
Arms & Interventions
Experimental Group
The experimental group will receive 2mA of anodal transcranial direct current stimulation (tDCS) for 20 minutes daily for 5 consecutive days.
Intervention: transcranial direct current stimulation (tDCS) (Device)
Sham Group
The sham group will be connected to the anodal transcranial direct current stimulation device daily for 5 days. During the 20 minute sessions, the participant will only receive stimulation for a 30-second ramp up period, at which point the stimulation will be discontinued for the remainder of the time.
Intervention: Sham (No Treatment) (Device)
Outcomes
Primary Outcomes
Finger and Toe-Tapping on KinesiaOne Device
Time Frame: 30 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session
We will use the KinesiaOne measure the finger tapping and foot tapping for 15 seconds. It will repeat 3 times at 1 minute intervals. KinesiaOne is a light-weight device that can be attached to the Index finger or ankle. It measures the acceleration and deceleration of the finger or foot. The measurement is transmitted to the KinesiaOne tablet that allows further data processing.
Secondary Outcomes
- The Multidimensional Fatigue Inventory (MFI)(5 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session)
- Center for Epidemiological Studies Depression Scale (CES-D).(5 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session)
- McGill Quality of Life (QOL) Scale(1 minute; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session)
- MDS-UPDRS Part II (patient self-report)(10 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session)
- Montreal Cognitive Assessment (MOCA)(8 minutes; pre-test during the second research visit.)