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

Primary Purpose

Apathy, Mild Cognitive Impairment

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Neurostar repetitive transcranial magnetic stimulator

About this trial

This is an interventional treatment trial for Apathy focused on measuring Mild Cognitive Impairment, apathy, executive function

Eligibility Criteria

55 Years - 91 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Subjects taking medications known to increase the risk of seizures from the 2012 Beers criteria: Bupropion, chlorpromazine, clozapine, maprotiline, olanzapine, thioridazine, thiothixene, and tramadol.
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.
Subjects taking ototoxic medications: Aminoglycosides, Cisplatin.
Subjects in current episode of major depression
History of bipolar disorder
Subjects with history of seizure or first degree relative with seizure disorder
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
Subjects with diagnosis of current alcohol related problems
Subjects with history of stroke , aneurysm, or cranial neurosurgery
Any condition that in the opinion of the study physician is likely to compromise their ability to safely participate in the study

Sites / Locations

Central Arkansas Veterans Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

transcranial magnetic stimulator

Sham coil treatment

Arm Description

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.

Neurostar repetitive transcranial magnetic stimulator. 10 treatments identical in duration will be administered over a two week period.

Outcomes

Primary Outcome Measures

Apathy Evaluation Scale (AES)

AES is an 18-item scale that assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks.

Secondary Outcome Measures

Trials making test

Widely used test for assessment of executive function.

Full Information

NCT ID

NCT02190019

First Posted

July 11, 2014

Last Updated

February 9, 2016

Sponsor

Central Arkansas Veterans Healthcare System

1. Study Identification

Unique Protocol Identification Number

NCT02190019

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Arkansas Veterans Healthcare System

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apathy, Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment, apathy, executive function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

transcranial magnetic stimulator

Arm Type

Active Comparator

Arm Description

Arm Title

Sham coil treatment

Arm Type

Sham Comparator

Arm Description

Neurostar repetitive transcranial magnetic stimulator. 10 treatments identical in duration will be administered over a two week period.

Intervention Type

Device

Intervention Name(s)

Neurostar repetitive transcranial magnetic stimulator

Other Intervention Name(s)

rTMS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Apathy Evaluation Scale (AES)

Description

AES is an 18-item scale that assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Trials making test

Description

Widely used test for assessment of executive function.

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

Exit 25

Description

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.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

91 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects age ≥ 55 years, Subjects meeting Petersen's criteria for MCI, Apathy Evaluation Scale-Clinician (AES-C) score of ≥ 30, Mini Mentla Status Examination (MMSE) ≥ 23, Subjects who clear the TMS adult safety scale (TASS) On stable dose of antidepressants (if applicable) for at least two months Exclusion Criteria: Subjects taking medications known to increase the risk of seizures from the 2012 Beers criteria: Bupropion, chlorpromazine, clozapine, maprotiline, olanzapine, thioridazine, thiothixene, and tramadol. 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. Subjects taking ototoxic medications: Aminoglycosides, Cisplatin. Subjects in current episode of major depression History of bipolar disorder Subjects with history of seizure or first degree relative with seizure disorder 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 Subjects with diagnosis of current alcohol related problems Subjects with history of stroke , aneurysm, or cranial neurosurgery Any condition that in the opinion of the study physician is likely to compromise their ability to safely participate in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prasad R Padala, MD, MS

Organizational Affiliation

Central Arkansas Veterans Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Arkansas Veterans Healthcare System

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29331848

Citation

Padala PR, Padala KP, Lensing SY, Jackson AN, Hunter CR, Parkes CM, Dennis RA, Bopp MM, Caceda R, Mennemeier MS, Roberson PK, Sullivan DH. Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study. Psychiatry Res. 2018 Mar;261:312-318. doi: 10.1016/j.psychres.2017.12.063. Epub 2018 Jan 5.

Results Reference

derived

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

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