Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD (tDCS)

Sanford Health

Status: Enrolling

Conditions: Parkinsons Disease (PD)

Treatments: Device: transcranial direct current stimulation (tDCS); Device: Sham (No Treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT06883266

SH tDCS-Motor-PD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Experimental Group

Experimental group

Description:

The experimental group will receive 2mA of anodal transcranial direct current stimulation (tDCS) for 20 minutes daily for 5 consecutive days.

Treatment:

Device: transcranial direct current stimulation (tDCS)

Sham Group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham (No Treatment)