A randomized controlled trial of Theta Burst Stimulation for the treatment of mild to moderate Alzheimer’s disease

Not Applicable

Completed

• Conditions: Alzheimer’s disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12615000992505
• Lead Sponsor: Professor Paul Fitzgerald

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-22
• Study Completion: 2021-08-01
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

100 individuals with AD will participate in the study. Participants will be included if they: (1) are competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study, as assessed by a clinical staff member independent of the research project; (2) have a diagnosis of AD based on general medical, neurological, and neuropsychological examinations according to the National Institute of Neurological and Communication Disorders–Alzheimer’s Disease and Related Disorders Association (NINCDS–ADRDA) criteria for probable Alzheimer’s disease and the DSM-IV clinical criteria for dementia of the Alzheimer’s type; (3)meet criteria for mild-to-moderate AD as indicated by a score of 12 or above on the Mini-Mental State Evaluation (MMSE); and (4) are either not on psychotropic medication or their dose of medication has been unchanged for a minimum of 4 weeks prior to entry into the study. Medication dose will not be able to be altered during participation: if this is clinically required the patient will be withdrawn from the study.

Exclusion Criteria

Patients will be excluded if they (1) have metal in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device ;(2) have a DSM-IV history of substance abuse or dependence in the last 6 months; (3) have a concomitant major and unstable medical, psychiatric or neurological illness; (4) have a history of seizures (5) are pregnant or breast feeding; (6) have had brain stimulation in the past three months or (7) are professional drivers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We will use the Alzheimer’s Disease Assessment Scale – Cognition (ADAS-COG) as our primary outcome measure. This is the standard diagnostic and severity assessment tool for AD).[At baseline, week 3 and week 6 of treatment, as well as at 3 and 6 month follow up appointments. ];We will also utilize the CogState Alzheimer’s battery. The CogState Alzheimer’s battery is a series of computerized tasks designed to sensitively assess the cognitive domains affected in AD including attention, speed of processing, learning and memory, visuospatial ability and executive function. It has been specifically developed for repeat use in clinical trials of AD.[At baseline, week 3 and week 6 of treatment, as well as at 3 and 6 month follow up appointments. ];A quality of life assessment designed specifically for AD, i.e. the AD-QOL will also be used.[At baseline, week 3 and week 6 of treatment, as well as at 3 and 6 month follow up appointments. ]

Secondary Outcome Measures

Name	Time	Method
Transcranial Magnetic Stimulation -Electroencephalography Assessment (TMS-EEG). TMS-EEG is performed by stimulating the scalp over the DLPFC while simultaneously recording brain activity via surrounding EEG electrodes. The TMS pulse produces a neurophysiological response in the underlying cortex, referred to as a TMS evoked potential (TEP), which is recorded on EEG and the TEP amplitude gives an index of cortical excitability.[We will conduct the TMS-EEG assessment at baseline and the week 6 assessment only.]