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NCT06883266 | RECRUITING | Parkinsons Disease (PD)


Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD
Sponsor:

Sanford Health

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.

Condition or disease

Parkinsons Disease (PD)

Intervention/treatment

transcranial direct current stimulation (tDCS)

Sham (No Treatment)

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 64 participants
Masking : DOUBLE
Masking Description : The participant and their care provider will be blinded as to which intervention is being used.
Primary Purpose : TREATMENT
Official Title : Transcranial Direct Current Stimulation (tDCS) to Improve Motor Function and Motor Fatigue in Parkinson's Patients
Actual Study Start Date : 2024-11-11
Estimated Primary Completion Date : 2026-11-11
Estimated Study Completion Date : 2026-12-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)

Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD

Location Details

NCT06883266


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Locations


RECRUITING

United States, North Dakota

Sanford Brain and Spine Center

Fargo, North Dakota, United States, 58103

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