Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia

NCT02190084 | Completed Phase 4

• 1 other identifier: 547461
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's Dementia (AD) is a major public health problem. Apathy, a profound loss of motivation, is seen in majority of patients with AD. Dysfunction of the front of the brain and loss of dopamine, a type of neurochemical, in this part of brain results in apathy. Presence of apathy is linked to deficits in planning sequential tasks such as keeping a routine. Patients with apathy have poor physical function and their caregivers experience extra burden. Unfortunately there are no good medications to treat apathy. FDA has approved the use of brain stimulation by a magnet known as repetitive transcranial magnetic stimulation (rTMS), for treatment of depression. rTMS increases dopamine when applied to frontal lobe of brain so we propose that rTMS would be a good treatment option for apathy in AD. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and executive function better than sham treatment in those with AD.

Conditions

Apathy; Alzheimer's Dementia

Keywords

apathy; Alzheimer's; 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.

  4 weeks

Secondary Outcomes (1)

• Trials making test

  4 weeks

Other Outcomes (1)

• Exit 25

  4 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. 20 treatment sessions are given over a four week period.

Device: Neurostar repetitive transcranial magnetic stimulator

Sham coil treatment

SHAM COMPARATOR

Neurostar repetitive transcranial magnetic stimulator. 20 treatments identical in duration will be administered over a four 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. 20 treatment sessions are given over a four 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,
• Diagnosis of Alzheimer's dementia meeting the DSM-IV TR criteria,
• Apathy Evaluation Scale-Clinician (AES-C) score of ≥ 30,
• Mini Mental Status Examination (MMSE) ≥ 18,
• Subjects who clear the TMS adult safety scale (TASS)
• On stable dose of antidepressants or dementia medicines (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, Boozer EM, Lensing SY, Parkes CM, Hunter CR, Dennis RA, Caceda R, Padala KP. Neuromodulation for Apathy in Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled Pilot Study. J Alzheimers Dis. 2020;77(4):1483-1493. doi: 10.3233/JAD-200640.

  PMID: 32925060 DERIVED

MeSH Terms

Conditions

Lethargy; Alzheimer Disease

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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: May 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

US (1)