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

Professor Paul Fitzgerald0 sites60 target enrollmentSeptember 22, 2015

Overview

No summary available.

Registry

who.int

Start Date

September 22, 2015

End Date

August 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Professor Paul Fitzgerald

•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Medication dose will not be able to be altered during participation: if this is clinically required the patient will be withdrawn from the study.

•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.