Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment:Pilot Study

February 9, 2016 updated by: Prasad R. Padala, Central Arkansas Veterans Healthcare System
Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients with apathy, rTMS to the frontal lobe might be helpful in treating the same. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and executive function better than sham treatment in those with MCI

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients with apathy, rTMS to the frontal lobe might be helpful in treating the same.

Specific Aims:

  • To determine the efficacy of rTMS to the dorsolateral prefrontal cortex (DLPFC) in treating apathy in MCI in comparison to sham treatment.
  • To compare the efficacy of rTMS to the DLPFC on executive function in MCI in comparison to sham treatment.

Research Plan: Current study is a randomized sham controlled cross-over study of daily rTMS.

Methods: 20 subjects with MCI and apathy will be enrolled to randomize 8 to a total of 20 sessions of treatment (2 weeks sham, 2 weeks rTMS, with 4 weeks of washout period). Subjects will be randomly assigned to rTMS or sham treatment after consent. After 2 weeks of treatment there will be a 4 week period with no treatment. At the end of the 4-week wash out period, subjects will be crossed over to the next treatment arm (i.e. those who received rTMS in the beginning will receive sham treatment and vice versa). Subjects will be followed for four additional weeks after treatment. Apathy will be assessed using the Apathy Evaluation Scale. Memory, executive function, functional status and caregiver burden will be assessed.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Veterans Healthcare System

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 to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects age ≥ 55 years,
  2. Subjects meeting Petersen's criteria for MCI,
  3. Apathy Evaluation Scale-Clinician (AES-C) score of ≥ 30,
  4. Mini Mentla Status Examination (MMSE) ≥ 23,
  5. Subjects who clear the TMS adult safety scale (TASS)
  6. On stable dose of antidepressants (if applicable) for at least two months

Exclusion Criteria:

  1. Subjects taking medications known to increase the risk of seizures from the 2012 Beers criteria: Bupropion, chlorpromazine, clozapine, maprotiline, olanzapine, thioridazine, thiothixene, and tramadol.
  2. Subjects taking medications known to increase seizure threshold not listed in the Beers criteria but in the opinion of PI increase seizure threshold: tricyclic antidepressants, theophylline, methylphenidate, and high-dose thyroid supplementation.
  3. Subjects taking ototoxic medications: Aminoglycosides, Cisplatin.
  4. Subjects in current episode of major depression
  5. History of bipolar disorder
  6. Subjects with history of seizure or first degree relative with seizure disorder
  7. Subjects with implanted device: wearable or implantable cardioverter defibrillators, conductive, ferromagnetic, or other magnetic sensitive metals that are implanted or are non-removable within 30 cm of the treatment coil or those with cochlear implants
  8. Subjects with diagnosis of current alcohol related problems
  9. Subjects with history of stroke , aneurysm, or cranial neurosurgery
  10. Any condition that in the opinion of the study physician is likely to compromise their ability to safely participate in the study

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transcranial magnetic stimulator
Neurostar repetitive transcranial magnetic stimulator. The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period.
Device: Neurostar repetitive transcranial magnetic stimulator
The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period.
Other Names:
  • rTMS
Sham Comparator: Sham coil treatment
Neurostar repetitive transcranial magnetic stimulator. 10 treatments identical in duration will be administered over a two week period.
Device: Neurostar repetitive transcranial magnetic stimulator
The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period.
Other Names:
  • rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apathy Evaluation Scale (AES)
Time Frame: 8 weeks
AES is an 18-item scale that assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trials making test
Time Frame: 8 weeks
Widely used test for assessment of executive function.
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exit 25
Time Frame: 8 weeks
EXIT-25 is a bedside measure of executive function. It defines the behavioral sequelae of executive dyscontrol and provides a standardized clinical encounter in which they can be observed.
8 weeks

Collaborators and Investigators

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

Sponsor

Central Arkansas Veterans Healthcare System

Investigators

  • Principal Investigator: Prasad R Padala, MD, MS, Central Arkansas Veterans Healthcare System

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

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 391721

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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