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

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ClinicalTrials.gov Identifier: NCT03590327
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : May 17, 2019
Sponsor:
Collaborators:
Central Arkansas Veterans Healthcare System
University of Arkansas
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Apathy Mild Cognitive Impairment Transcranial Magnetic Stimulation Device: Transcranial Magnetic Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03590327


Contacts
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Contact: Prasad R Padala, MBBS (501) 257-2537 Prasad.Padala@va.gov

Locations
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United States, Arkansas
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR Recruiting
North Little Rock, Arkansas, United States, 72114-1706
Contact: Prasad R Padala, MBBS    501-257-2537    Prasad.Padala@va.gov   
Principal Investigator: Prasad R. Padala, MBBS         
Sponsors and Collaborators
VA Office of Research and Development
Central Arkansas Veterans Healthcare System
University of Arkansas
Investigators
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Principal Investigator: Prasad R. Padala, MBBS Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03590327     History of Changes
Other Study ID Numbers: D2638-R
1115904 ( Other Identifier: Central Arkansas Veterans Healthcare System )
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders