Efficacy of Transcranial Direct Current Stimulation In Parkinson's Disease MCI

NCT04171804 | Completed

• 1 other identifier: 2018-055
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to investigate the efficacy of prefrontal transcranial Direct Current Stimulation (tDCS) on cognitive functions and electrophysiological measures in Parkinson's Disease Mild Cognitive Impairment (PD-MCI). The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS (twice a day) for 5 days. The study will also examine if the effects may last for a month. The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS (twice a day) for 5 days. The study will also examine if the effects may last for a month.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Mild Cognitive Impairment; Transcranial Direct Current Stimulation; Cognitive functions; Electrophysiology; Event related potentials

Outcome Measures

Primary Outcomes (12)

• Changes in response conflict in the Stroop Test during the study period

  The stroop effect consists of the semantic and the response conflict. Response conflict (time in milliseconds) is obtained by subtracting the semantic conflict (time in milliseconds obtained in the second step of the protocol) from the stroop effect (time in milliseconds obtained in the first step of the protocol). Minimum time difference is 0 and maximum time difference is 100 milliseconds. Lower time differences indicate better performance and higher time differences indicate worse performance.

  Up to one month

• Change in the verbal fluency performance during the study period

  Verbal fluency is a test that measure multiple domains of cognition such as executive functions and language functions. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds, the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds. Minimum score is 0 and maximum score is 80. Lower scores indicate worse performance and higher scores indicate better performance.

  Up to one month

• Changes in Trail Making A Test performance during the study period

  Trail Making A Test is a widely used as a quick and easy to administer measure of attention. Lower reaction times indicate better performance and higher reaction times indicate worse performance. Minimum time is 10 milliseconds and maximum time is 150 milliseconds.

  Up to one month

• Changes in digit span during the study period

  The Digit Span test is a measure of verbal short-term/working memory. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. Digit span forward total score: 0-10; higher score indicate better performance, digit span backwards total score: 0-10; higher score indicate better performance

  Up to one month

• Changes in delayed recall performance during the study period

  Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance.

  Up to one month

• Changes in verbal memory processes performance during the study period

  The Verbal Memory Processes Test is a 15-word word-list learning test with a 40-minute delayed recall addition based on the Rey Auditory Verbal Learning Test which gives the opportunity to evaluate the processes of working memory, learning or acquiring knowledge, retention of information, and recalling. It consists of immediate recall, learning score and a 40-min delayed recall test, followed by total recall. Higher scores indicate better performance in all indexes of the test. Minimum scores are 0 and maximum scores are 15 for immediate recall, delayed recall and total recall and 150 for learning score, respectively.

  Up to one month

• Changes in face recognition performance during the study period

  Benton Facial Recognition Test is a common test assessing visuo-spatial functions. It was developed by Benton in 1969. It is standardized to determine the capacity to identify and distinguish unrecognized human faces. This test consists of 22 pages of A4 size and there are face pictures on these pages. Only one page of pages is numbered. There is a stimulant picture on pages with no page numbers. Numbered pages have 6 pictures to select from among the responses. The application period of the test is 5-15 minutes and the time factor is not evaluated separately. Higher scores indicate better performance and lower scores indicate worse performance. Minimum score is 0 and maximum score is 54.

  Up to one month

• Changes in judgment of line orientation performance during the study period

  A test of visuospatial judgement. The test measured the participant's ability to match the angle and orientation of lines in space. There were 30 trial in total. Correct response in a trial was awarded one point. Minimum score is 0 and maximum score is 30. Higher scores represent better performances.

  Up to one month

• Changes in the naming performance during the study period

  The naming performance will be measured by the Boston Naming Test Short Form and Responsive Naming Test. Boston Naming Test consists of 45 pictures to be named. Minimum score is 0 and maximum score is 45. Higher scores indicate better performance and lower scores indicate worse performance. In the Responsive Naming Test, participants answer the questions such as "What do women apply to their lips?" Minimum score is 0 and maximum score is 10. Higher scores indicate better performance and lower scores indicate worse performance.

  Up to one month

• Changes in amplitudes (in microvolts) for parameters from the ERP tests during the study period for parameters from the ERP tests during the study period

  Amplitudes (in microvolts) for the following parameters from the ERP tests will be collected as primary endpoints:N1, P3 and other common wave forms for both Two-tone auditory oddball paradigm and Continuous Performance Test ERP paradigms.

  Up to one month

• Changes in detection sensitivity from the behavioral responses during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms during the study period

  Detection sensitivity from Signal Detection Theory (d', calculated as \[zFA - zHR\], where z is the inverse of the standard normal cumulative distribution, FA is the false-alarm rate \[the proportion of responses made to stimuli that were not targets\], and HR is the hit rate \[the proportion of correct identifications of target stimuli\]) during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms will be measured.

  Up to one month

• Changes in reaction times from the behavioral responses during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms during the study period

  Reaction times for the correct behavioral responses during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms will be measured.

  Up to one month

Secondary Outcomes (1)

• Correlation between changes in behavioral measures and changes in amplitudes of ERP components

  Up to one month

Study Arms (2)

Active

ACTIVE COMPARATOR

Left anodal/right anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex

Device: Transcranial direct current stimulation

Sham

SHAM COMPARATOR

Sham transcranial direct current stimulation over the dorsolateral prefrontal cortex

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

Participants will receive a total of 10 stimulation sessions on 5 consecutive days (twice a day with 3-4 hours interval). During each session, 2 milliAmpers (mA) of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (left anodal/right anodal).

Also known as: tDCS, Direct current stimulation, transcranial electrical stimulation

Active; Sham

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability) in accordance with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria, issued by a neurologist specializing in movement disorders;
• Disease staging between I and III, according to the modified Hoehn and Yahr scale;
• Clinical diagnosis of PD- MCI in accordance with Level 2 Movement Disorders Society- Task Force diagnostic criteria;
• An unchanged stable and optimal regimen of dopaminergic medication for at least one month before study entry and able to continue on a stable regimen for the duration of the study;
• Ability to provide written informed consent;
• or more years of education;
• Right-hand dominancy;
• Not taking any psychoactive medications before the previous month of the study and for the duration of the study;
• Naïve to tDCS.

You may not qualify if:

• Diagnosis or evidence of secondary or atypical parkinsonism;
• Patients with dementia;
• Less than 5 years of education;
• Previous history of surgical intervention for PD such as deep brain stimulation (DBS);
• Diagnosis of active major depressive disorder, psychotic disorders, bipolar disorder, alcohol use disorder and substance use disorders;
• Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for \> 5 minutes and retrograde amnesia for \> 30 minutes;
• Significant hearing loss or visual impairment;
• Diagnosis of any serious or uncontrolled medical condition such as chronic obstructive pulmonary disease, congestive heart failure or renal failure;
• Skin diseases that could potentially cause irritations under electrodes
• Patients missing two consecutive protocol sessions;
• Illiteracy, deficient language or refusal to participate or being not able to follow instructions or complete study tasks;.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Serkan Aksu

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 21, 2019
• Study Start: January 1, 2019
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)