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Transcranial Direct Current Stimulation for Cognitive Improvement in Parkinson's Mild Cognitive Impairment (tDCS) (tDCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03191916
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Sanford Health

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 cognitive function and reducing cognitive fatigue and fatigability in PD patients with MCI.

Condition or disease Intervention/treatment Phase
Parkinson Disease Mild Cognitive Impairment Device: transcranial direct current stimulation Device: Sham (for transcranial direct current stimulation) Not Applicable

Detailed Description:

Parkinson's disease (PD) is the second most common neurodegenerative disease (after Alzheimer's disease) and affects approximately one million people in the United States. Mild Cognitive Impairment (MCI) is very common even in early stages of PD. In addition to cognitive impairment, patients with PD also suffer cognitive fatigue (defined as the general sensation of difficulty in initiating cognitive activity) and cognitive fatigability (defined as "deterioration in the performance of attention tasks over an extended period of time"). Cognitive impairment, cognitive fatigue, and cognitive fatigability affect quality of life in patient 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 cognitive 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 cognitive function and reduce cognitive fatigue and fatigability in PD patients with MCI. The study will examine if the effects may last for two weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Double (Participant, Care Provider)
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 Cognitive Function and Cognitive Fatigue in Parkinson's Patient Mild Cognitive Impairment (MCI)
Actual Study Start Date : October 19, 2015
Estimated Primary Completion Date : August 7, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
The experimental group will receive 2 milliamps of anodal transcranial direct current stimulation for 20 minutes daily for 5 days.
Device: transcranial direct current stimulation
2milliamps will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.
Other Names:
  • Magstim
  • HDCstim
  • HDCkit

Sham Comparator: 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.
Device: Sham (for transcranial direct current stimulation)
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 Outcome Measures :
  1. Change in Reaction Time (RT) on contextual cueing computer task [ Time Frame: 90 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 ]
    A visual search task will be given in which the participant looks for a T among L's. The contextual cuing task will consist of a practice block and forty test blocks. Eight of the trials in a block will consist of search configurations that repeat from block to block (repeat configurations); the other eight trials in a block will be randomly-generated configurations (new configurations). After the final trial, a recognition task will be presented to determine whether participants realized that repeat configurations were presented (not expected; cueing effects appear to result from implicit learning). Reaction time for each block will be recorded, with cognitive fatigue measured as deterioration of RT over the 40 blocks. This measure of change in RT will be compared across the 4 visits (pre-test, 6th visit, 7th visit, and 8th visit). Improved cognition fatigue based on tDCS treatment would predict reduced change in RT in the later visits compared to the pre-test.


Secondary Outcome Measures :
  1. Change in Error Rate on contextual cueing computer task [ Time Frame: 90 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 ]
    A visual search task will be given in which the participant looks for a T among L's. The contextual cuing task will consist of a practice block and forty test blocks. Eight of the trials in a block will consist of search configurations that repeat from block to block (repeat configurations); the other eight trials in a block will be randomly-generated configurations (new configurations). After the final trial, a recognition task will be presented to determine whether participants realized that repeat configurations were presented (not expected; cueing effects appear to result from implicit learning). Error rate for each block will be recorded, with cognitive fatigue measured as increased errors over the 40 blocks. This measure of change in error rate will be compared across the 4 visits (pre-test, 6th visit, 7th visit, and 8th visit). Improved cognition fatigue based on tDCS treatment would predict reduced change in error rate in the later visits compared to the pre-test.

  2. 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. Neuropsychological battery (Stroop and Digit Span) [ 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 ]
    The Stroop Test is a measure of processing speed, attention, and inhibition. In Stroop A, the participant is required to read color words (e.g., Red, Green, etc.) out loud quickly for 45 seconds. In Stroop B, the participant is required to name ink colors out loud as quickly as possible for 45 seconds. In Stroop C, the participants are required to name the color ink of opposing color words (e.g., the word "blue" written in red ink with the correct response being "red"). Digit Span forward is a measure of simple attention. Participants repeat progressively longer series of numbers until the participant can no longer complete the task. Digit Span Backward is a measure of working memory. The participant repeats back a series of numbers in reverse order. The series length increase until the participant can no longer complete the task.

  6. Montreal Cognitive Assessment (MOCA) [ Time Frame: 8 minutes; pre-test during the second research visit and post-test on 8th visit 14 days after last tDCS session ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability)
  • Meets criteria for MCI (21 ≤ MOCA scores ≤ 26)
  • 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 epilepsy
  • Diagnosis of chronic obstructive pulmonary disease
  • Diagnosis of congestive heart failure
  • Diagnosis of renal failure
  • Participants not fluent in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191916


Contacts
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Contact: Asenath X Huether, PhD 701-234-4170 parkinsonsresearch@sanfordhealth.org

Locations
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United States, North Dakota
Sanford Brain & Spine Center Recruiting
Fargo, North Dakota, United States, 58103
Contact: Asenath X Huether, MS    701-234-4170    parkinsonsresearch@sanfordhealth.org   
Principal Investigator: Jau-Shin Lou, MD         
Sponsors and Collaborators
Sanford Health
Investigators
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Principal Investigator: Jau-Shin Lou, MD Sanford Health
Publications:
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Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT03191916    
Other Study ID Numbers: SH tDCS Parkinsons
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sanford Health:
Parkinson's Disease
Mild Cognitive Impairment
tDCS
Cognitive function
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders