Brain Functional Changes Accompany Modulatory Effects of Transcranial Direct Current Stimulation in Cognitive Impairment

NCT06864910 | Completed

• 2 other identifiers: DST-CSI/002/208/2018/01156DST/CSRI/2017/249 (G) 28.08.18
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study was to examine the brain functional alterations accompanying cognitive modulatory effect of anodal transcranial Direct Current Stimulation (tDCS) in sample patients with early Alzheimer's Disease (AD), registered under Geriatric Clinic and Services at NIMHANS, and who were initiated on tDCS for cognitive enhancement. Further, to explore the potential beneficial effect of tDCS, the investigators offered the intervention to the first 40 consenting patients from the amnestic Mild Cognitive Impairment (aMCI) (n=21) and mild AD (n=19) samples. The changes in functional connectivity/activations associated with diminished cognitive functions were examined using functional magnetic resonance imaging (fMRI) and magnetoencephalography (MEG), between pre- and post-tDCS intervention. The administration of tDCS followed the standard procedures using a neuroConn DC-Stimulator Plus device (neuroCare Group GmbH, Munich, Germany) with the anode placed at F3 (left DLPFC) and the cathode over the right supraorbital region (Fp2) using 5x7cm electrodes. The anodal tDCS intervention involved daily sessions (between 10-11 a.m.) for 10 consecutive days, wherein a direct current (DC) of 2 mA was administered for 20 minutes (with additional ramp-up and ramp-down phase of 20 seconds each at the beginning and end of the session respectively), adhering to stringent safety measures.

Conditions

Cognitive Impairment

Keywords

transcranial Direct current Stimulation; Alzheimer Disease; Mild Cognitive Impairment; functional Magnetic Resonance Imaging; Magnetoencephalography

Outcome Measures

Primary Outcomes (3)

• Magnetic Resonance Imaging

  The resting state functional connectivity, incidental encoding and intentional retrieval task based activation were the primary outcome measures of MRI.

  After the completion of 10 sessions of tDCS (one session per day) spanning across a maximum of 14 days

• Magnetoencephalography

  The power of alpha, beta, theta and gamma bandwidths, phase of theta waves and amplitude of gamma band coupling in the left entorhinal cortex were calculated as primary outcome measure of magnetoencephalography

  After the completion of 10 sessions of tDCS (one session per day) spanning across a maximum of 14 days

• Cognitive assessments

  The output of NIMHANS Neuropsychological Battery for Elderly (NNB-E) measuring tests of episodic memory, executive functions, attention, visuospatial function, and parietal focal signs were noted as primary outcome measures of the cognitive assessments used in this study.

  After the completion of 10 sessions of tDCS (one session per day) spanning across a maximum of 14 days

Study Arms (1)

early Alzheimer's Disease (AD)

The early AD group comprised of patients with Mild Cognitive Impairment (MCI) and mild Alzheimer's Disease (AD)

Device: anodal transcranial Direct Current Stimulation

Interventions

anodal transcranial Direct Current Stimulation DEVICE

Transcranial direct current stimulation was administered following standard procedures using a neuroConn DC-Stimulator Plus device (neuroCare Group GmbH, Munich, Germany) with the anode placed at F3 (left DLPFC) and the cathode over the right supraorbital region (Fp2) using 5x7cm electrodes. The anodal tDCS intervention involved daily sessions (between 10-11 a.m.) for 10 consecutive days, wherein a direct current (DC) of 2 mA was administered for 20 minutes (with additional ramp-up and ramp-down phase of 20 seconds each at the beginning and end of the session respectively), adhering to stringent safety measures . None of the participants reported significant adverse effects.

early Alzheimer's Disease (AD)

Eligibility Criteria

• Age: 55 Years+
• Gender Eligibility Details: Males and Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients aged 55 and above attending the Geriatric Clinic and Services at NIMHANS with memory complaints who fulfil the following inclusion and exclusion criteria will be considered for recruitment into the study. Those diagnosed as Minimal Cognitive Impairment or Mild Alzheimer's Dementia by two consultants according to National Institute of Aging and Alzheimer's Association criteria and a Clinical Dementia Rating (CDR) of 0.5 for MCI and 1 for Mild AD would be recruited. Consenting cognitively healthy elderly subjects matched for age and gender to the above with CDR \< 0.5 would be parallely recruited.

You may qualify if:

• Elderly aged 55 years or above
• Both genders
• Only right handed individuals
• Elderly with a diagnosis of Minimal Cognitive Impairment and Mild AD according to National institute of Ageing -Alzheimer's Association (NIAAA) diagnostic Criteria and 0.5 for MCI and 1 according to CDR criteria.
• Informed consent

You may not qualify if:

• Elderly with more advanced dementia (CDR \>1)
• Patients on medications like antipsychotics, antidepressants and benzodiazepines (some of patients).
• Patient with comorbid clinical conditions like hypothyroidism, hypercalcemia, vitamin B12 deficiency, niacin deficiency, neurosyphilis, normal pressure hydrocephalus or subdural haematoma.
• Persons with other mental disorders like schizophrenia and related disorder, bipolar affective disorder, severe depression, obsessive compulsive disorder, substance dependence and mental retardation.
• History of neurological illness like stroke, epilepsy, head injury with significant loss of consciousness or other chronic neurological/ neurodegenerative conditions.
• Elderly Cognitively Healthy Comparison group (n=50)
• Elderly aged 55 years or above (age, gender and education matched with Dementia subjects)
• Persons without MCI/AD (NIAAA Criteria)
• Both genders, only right handed individuals.
• Elderly with MCI or dementia (CDR ≥0.5)
• Patients on medications like antipsychotics, antidepressants and benzodiazepines (some of patients).
• Patient with comorbid clinical conditions like hypothyroidism, hypercalcemia, vitamin B12 deficiency, niacin deficiency, neurosyphilis, normal pressure hydrocephalus or subdural haematoma.
• Persons with other mental disorders like schizophrenia and related disorder, bipolar affective disorder, severe depression, obsessive compulsive disorder, substance dependence and mental retardation.
• History of neurological illness like stroke, epilepsy, head injury with significant loss of consciousness or other chronic neurological/ neurodegenerative conditions.

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

Study Sites (2)

National Institute of Mental Health and Neurosciences (NIMHANS)

Bengaluru, Karnataka, India

Location

National Institute of Mental Health and Neurosciences

Bengaluru, Karnataka, India

Location

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MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• John P John, M.D.

  National Institute of Mental Health and Neuro Sciences, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 7, 2025
• Study Start: August 5, 2019
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)