Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment (TAMCI)

December 7, 2023 updated by: VA Office of Research and Development

Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild memory problems. Their motivation, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the front part of their brain over 20 sessions. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.

A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment.

Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD.

Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD.

Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild cognitive impairment. Their motivation, other behavioral problems, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the dorsolateral prefrontal cortex over 20 daily sessions on consecutive week days. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.

A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment.

Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD.

Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD.

Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72114-1706
        • Recruiting
        • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
        • Contact:
        • Principal Investigator:
          • Prasad R. Padala, MBBS MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • meeting the modified Mayo Clinic criteria for MCI
  • Having caregivers
  • apathy threshold (NPI)
  • MMSE 23
  • On stable dose of antidepressants for at least a month (if applicable)

Exclusion Criteria:

PHASE I

  • Uncontrolled diabetes mellitus (Fasting BS>200mg/dl, HbA1c>10)
  • Renal disease requiring dialysis
  • Uncontrolled blood pressure (>160/100, <100 systolic)
  • Metastatic cancer or undergoing chemotherapy
  • Deep venous thrombosis or myocardial infarction in past 3 months
  • Uncontrolled malignant cardiac arrhythmia
  • Cerebral aneurysm or intracranial bleed in past year
  • Unstable angina in past month
  • Unstable abdominal or thoracic aortic aneurysm (>4cm)
  • End-stage congestive heart failure

EXCLUSIONARY DUE TO rTMS: ALL PHASE II AND SUBSET OF PHASE I THAT RECEIVE SINGLE SESSION rTMS

  • Taking medications known to increase risk of seizures from 2012 Beers criteria such as bupropion, chlorpromazine, clozapine.
  • Taking other medications known to increase risk of seizures such as tricyclic antidepressants.
  • Taking ototoxic medications: Aminoglycosides, Cisplatin
  • History of seizures/ seizures in first degree relatives
  • Those with implanted device
  • History of stroke, aneurysm, or cranial neurosurgery
  • History of bipolar disorder
  • Current alcohol related disorder needing medical treatment
  • History of Tourette's syndrome or presence of motor tics
  • History of abnormal electroencephalogram (EEG)

EXCLUSIONARY DUE TO CONFOUNDING WITH APATHY: PHASE II

  • Current episode of Major Depressive Disorder
  • Current use of stimulants
  • Change in dose of dementia medications within 30 days
  • Change in dose of antidepressants within 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Apathy +, rTMS -
This arm will be followed without intervention
Active Comparator: rTMS
This group will be randomized to receive rTMS treatment
Device: Transcranial Magnetic Stimulation
rTMS
Sham Comparator: Sham
This group will be randomized to receive sham treatment
Device: Transcranial Magnetic Stimulation
rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Apathy Evaluation Scale Score
Time Frame: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
Range 18-72 Lower score is improvement
2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Mini Mental State Examination Score
Time Frame: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
Range 0-100 Higher score is improvement
2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
Change in Conner's Continuous Performance Test Commission Error percentage
Time Frame: 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months
Range 0-100% Higher score is improvement
2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Inventory - Questionnaire
Time Frame: Through study completion, an average of 1 year

To study the impact of COVID pandemic on neuropsychiatric symptoms of dementia. This outcome measure has questions pertaining to twelve neuropsychiatric symptoms seen in dementia. An aggregate score of the symptoms, caregiver distress and change during the COVID pandemic will be reported.

Presence or lack of each domain is reported for this study. No range in score for this scale.
Through study completion, an average of 1 year
Functional Activities Questionnaire
Time Frame: Through study completion, an average of 1 year
Measure of functional independence Range: 0-30 Higher score indicates higher dependence
Through study completion, an average of 1 year
UCLA Loneliness scale
Time Frame: Through study completion, an average of 1 year
Measures loneliness Range 3-9 Higher score indicates higher loneliness
Through study completion, an average of 1 year
T-MoCA
Time Frame: Through study completion, an average of 1 year
Measures global cognition Range: 0-22 Higher scores indicate better cognition
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

University of Arkansas
Central Arkansas Veterans Healthcare System

Investigators

  • Principal Investigator: Prasad R. Padala, MBBS MBBS, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2638-R
  • 1115904 (Other Identifier: Central Arkansas Veterans Healthcare System)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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