Clinical trial NCT06883266: Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD
Official title: Transcranial Direct Current Stimulation (tDCS) to Improve Motor Function and Motor Fatigue in Parkinson's Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinsons Disease (PD)
Keywords: Parkinsons Disease
tDCS
Motor Function
Motor Fatigue
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to an experimental group (receives stimulation) or a sham group (is set up with tDCS, but no stimulation is received)
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left dorsolateral prefrontal cortex (LDLPFC) 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 LDLPFC 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Finger and Toe-Tapping on KinesiaOne Device
timeFrame: 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
Secondary outcomes:
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: 8 minutes; pre-test during the second research visit.
measure: The Multidimensional Fatigue Inventory (MFI)
timeFrame: 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
measure: Center for Epidemiological Studies Depression Scale (CES-D).
timeFrame: 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
measure: McGill Quality of Life (QOL) Scale
timeFrame: 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
measure: MDS-UPDRS Part II (patient self-report)
timeFrame: 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
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Brain and Spine Center
state: North Dakota
Study officials:
affiliation: Sanford Health
name: Jau-Shin Lou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.