Clinical trial NCT05919485: The Effects of Specific tDCS on Cognition in MCI
Official title: The Effects of Specific Transcranial Direct Current Stimulation tDCS on Cognition in Mild Cognitive Impairment: A Novel Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Parkinson Disease
Keywords: Mild cognitive impairment
Alzheimer's disease
Parkinson's disease
Transcranial direct current stimulation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Alanya Alaaddin Keykubat University
First posted: 2023-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: INTRODUCTION:

Mild cognitive impairment (MCI) is a critical transitional stage in dementia related disorders. Dorsolateral prefrontal cortex (DLPFC), and the lateral parietal (LPC) cortex are subjected to neuropathological changes in MCI. Parietal memory network (PMN) integrity alterations and default mode network (DMN) alterations also occur in MCI. Transcranial direct current stimulation (tDCS) is a promising neuroprotective tool that modulates functional connectivity and might be useful to interfere with cognitive decline in relation to amnestic MCI (aMCI) and Parkinson's disease-MCI (PD-MCI) when applied to DLPFC and LPC.

METHODS:

This is a multicenter, randomized, and controlled study evaluating the effectiveness of anodal tDCS (atDCS ) applied bilaterally to the DLPFC/F3-F4 and LPC/ P3-P4 for 5 sessions with a total of 10 sessions in 14 days. The stimulation will be delivered with a 2 mA current frequency and will last 20 minutes a day for 5 days a week. The study consists of anodal, and sham control groups with a total of 120 participants with DLPFC and LPC anodal groups including 40 participants each and sham including 40 participants which are all between 45-80 years of age.

At baseline and as an outcome measure, neurocognitive evaluation will be conducted using various tests standardized to use in the Turkish population. Functional magnetic resonance (fMRI) will be used to detect possible PMN and DMN alterations and hippocampal connectivity, and electroencephalogram (EEG) will be used to assess possible electrophysiological alterations that may happen as a result of atDCS. Baseline evaluation will be done before atDCS sessions and it will be repeated at the end of 14 days and 90 days.

DISCUSSION:

This study aims to explore the effectiveness of atDCS in PD-MCI, aMCI and to contribute to the literature in the field.

Detailed description: Study Design This is a multi-center, randomized, controlled study registered and carried out at Medipol University Hospital and Alaaddin Keykubat University Training and Research Hospital. The objective of the study is to evaluate the effectiveness of atDCS stimulation over DLPFC and LPC on cognitive skills of patients with PD-MCI and aMCI.

The patients will be randomized to 2mA tDCS over DLPFC and over LPC, or Sham control. tDCS stimulation will last for 20 minutes a day for 5 consecutive days, a total of 10 sessions in 14 days. The outcome of the simulations will be evaluated by various neurocognitive tests at the baseline, at the end of 14 days and then, 90 days.

Brain connectivity will be analyzed by resting state-functional magnetic resonance imaging (fMRI) and neuronal activity will be analyzed by electroencephalography (EEG) at the baseline, at the end of 14 days and 90 days..

This study aims to give important translational messages in the field of clinical neuroscience by exploring the pro-cognitive effects of tDCS application including its optimal application methods. In this framework, the restorative benefits of tDCS can be critical to understand the cause-effect relationship between certain neural circuits and behavioral outcomes, which might be important in understanding the pathophysiology of MCI and PD. From another point of view, our findings might be valuable in terms of prolonged life-expectancy and the maintenance of preserved cognitive skills in the elderly.

Although tDCS is still in a premature stage, it has certain advantages in terms of portability, cost-effectiveness and user-friendly application compared to other non- invasive stimulation applications. This study will contribute to the growing literature in terms of its optimal application methods, side-effects and long-term (90 days) neurobehavioral results.

Eligibility criteria: Inclusion Criteria:

1. Providing an informed consent;
2. Literate and between 45-80 years of age;
3. 60 females and 60 males;
4. Diagnosed with PD based on criteria suggested by UK Parkinson's Disease Society, Brain Bank and PD-MCI in accordance with the diagnostic criteria suggestions by Litvan;
5. Diagnosed with aMCI based on diagnosis criteria (CDR\&gt;0.5) suggested by Petersen;
6. On a stable pharmacological treatment minimum for one month with no washout period.

Exclusion Criteria:

* Illiterate or education level less than primary school
* Having an existing and/or prior neurological disease; psychiatric disease or head trauma; and/or irreversible hearing or sight problems or other medical illness (e.g. diabetes mellitus, hypertension);
* Exhibiting signs of dementia for PD group ;
* Having medical issues that prevent undergoing fMRI or for tDCS application.

Primary outcomes:
measure: Neuropsychological Tests Scores
timeFrame: Changes Before Treatment and 14 Days&90 Days after treatment
Secondary outcomes:
measure: EEG Power Spectrum Analysis
timeFrame: Changes Before Treatment and 14 Days after treatment
measure: EEG Coherence Analysis
timeFrame: Changes Before Treatment and 14 Days after treatment
measure: EEG functional connectivity analysis
timeFrame: Changes Before Treatment and 14 Days after treatment
measure: Volumetric Magnetic resonance Imaging (MRI) and functional magnetic resonance imaging (rest-fMRI)
timeFrame: Changes Before Treatment and 14 Days after treatment
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Alaaddin Keykubat Üniversitesi
state: Alanya
Study officials:
References: