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NCT Number: NCT06883266

Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD

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.

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Key information

Conditions

Parkinsons Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanford Brain and Spine Center

Fargo, North Dakota, 58103, United States

Location status: Recruiting

Location contact

Jau-Shin Lou, MD

PRINCIPAL_INVESTIGATOR

Jessica Keller, B.S.

CONTACT

[email protected]

701-417-5781

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

2 mA will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.

Sham (No Treatment)

Device

For 30 seconds, the patient will experience a ramp up of the stimulation, after which point no stimulation will be transmitted for the remainder of the session. This will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex

Primary outcomes

  1. 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

  1. Montreal Cognitive Assessment (MOCA)

    Time frame: 8 minutes; pre-test during the second research visit.

    This is a tool used to screen for mild cognitive dysfunctions. It assesses different domains of cognition: attention, memory, language visuospatial skills, orientation, and calculations. It determines the cut-off for dementia.

  2. The Multidimensional Fatigue Inventory (MFI)

    Time frame: 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

    This is a 20-item self-report instrument that measures five dimensions of fatigue independently: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.

  3. Center for Epidemiological Studies Depression Scale (CES-D).

    Time frame: 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

    This is a tool used to screen for symptoms of depression.

  4. McGill Quality of Life (QOL) Scale

    Time frame: 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

    This is a single item tool to assess quality of life on all parts of life (physical, emotional, social, spiritual, and financial.

  5. MDS-UPDRS Part II (patient self-report)

    Time frame: 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

    This is a 20-item patient self-report questionnaire that assess the motor aspects of experiences of daily living.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Keller, B.S.

CONTACT

[email protected]

701-417-5781

Sponsors and collaborators

Lead sponsor

Sanford Health

Other

Registry information

Official study title

Transcranial Direct Current Stimulation (tDCS) to Improve Motor Function and Motor Fatigue in Parkinson's Patients

Acronym: tDCS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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