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

NCT02190019 | Unknown Phase 4

• 1 other identifier: 391721
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Apathy; Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; apathy; executive function

Outcome Measures

Primary Outcomes (1)

• Apathy Evaluation Scale (AES)

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

  8 weeks

Secondary Outcomes (1)

• Trials making test

  8 weeks

Other Outcomes (1)

• Exit 25

  8 weeks

Study Arms (2)

transcranial magnetic stimulator

ACTIVE COMPARATOR

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

Sham coil treatment

SHAM COMPARATOR

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

Device: Neurostar repetitive transcranial magnetic stimulator

Interventions

Neurostar repetitive transcranial magnetic stimulator DEVICE

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.

Also known as: rTMS

Sham coil treatment; transcranial magnetic stimulator

Eligibility Criteria

• Age: 55 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Arkansas Veterans Healthcare System: lead

Study Sites (1)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• 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.

  PMID: 29331848 DERIVED

MeSH Terms

Conditions

Lethargy; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Prasad R Padala, MD, MS

  Central Arkansas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director for Clinical Programs, GRECC

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 15, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2016
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

US (1)