N/A
N=22
Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01504958 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Jun 2017
Primary outcome: Primary: Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) — 1.79; -0.20; -0.66 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Repetitive Transcranial Magnetic Stimulation (rTMS) (Device); NICE Cognitive Training (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) |
1.79; -0.20; -0.66 | — |
| SECONDARY Clinical Global Impression of Change (CGIC) |
3.25; 4.40; 4.08 | — |
| SECONDARY Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) |
72.67; 73.60; 65.75; 69.78; 71.20; 61.75 | — |
Summary
This study looks at the potential benefits of combining cognitive training (mental exercises) together with transcranial magnetic stimulation (also known as TMS) to see if this can make a difference in the condition of people with Alzheimer's disease by improving their disease and the cognitive decline that goes along with it.
Eligibility Criteria
Inclusion Criteria
- Male or female age 55-90
- Diagnosed with mild to moderate AD according to DSM-IV criteria
- Diagnosis of dementia of the Alzheimer's type according to the criteria established by the NINCDS-ADRDA
- Normal or corrected normal ability to see and hear
- Primary language is English
Exclusion Criteria
- IQ below 85
- Any major structural abnormalities on MRI (eg. Infarction, intracerebral malformation)
- Any symptoms of disease or abnormalities sufficient to cause memory impairment other than AD (eg. Normal pressure hydrocephalus, progressive supranuclear palsy)
- Any functional psychiatric disorder (eg. Schizophrenia)
- Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (eg. Cardiac malformation)
- History of seizures, diagnosis of epilepsy
- Metal implants excluding dental fillings or any of the following medical devices: pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit (unless removed completely for this study), cerebral spinal fluid shunt
- Recent withdrawal from the following drugs: alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate
Data sourced from ClinicalTrials.gov (NCT01504958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.