This trial is active, not recruiting.

Condition alzheimer's disease
Treatment tms, h coil
Phase phase 2
Sponsor Brainsway
Start date August 2010
End date August 2015
Trial size 45 participants
Trial identifier NCT01179373, 10003


The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
(Active Comparator)
High Frequency TMS with H coil to prefrontal cortex
tms, h coil TransCranial Magnetic Stimulation
TMS, H Coil, High/ Low Frequency
(Active Comparator)
Low Frequency TMS to Prefrontal cortex
tms, h coil TransCranial Magnetic Stimulation
TMS, H Coil, High/ Low Frequency
(Placebo Comparator)
Sham TMS with H Coil on Prefrontal Cortex
tms, h coil TransCranial Magnetic Stimulation
TMS, H Coil, High/ Low Frequency

Primary Outcomes

cognitive functioning score by ADAS-COG
time frame: 4 months

Secondary Outcomes

Global advancement score by CGI-C
time frame: 4 months
Frontal lobe functioning score by FAB
time frame: 4 months
Daily activity score by ADL
time frame: 4 months

Eligibility Criteria

Male or female participants from 50 years up to 85 years old.

Inclusion Criteria: 1. Men and women aged 50-85. 2. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria). 3. Scored below 24 on the MMSE. 4. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response. 5. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire. 6. Gave their oral and written consent to participate in the trial. Exclusion criteria: 1. An additional neurological or psychiatric disorder. 2. Severe personality disorder. 3. Uncontrolled hypertension. 4. History of epilepsy, seizure, or heat convulsion. 5. History of epilepsy or seizure in first degree relatives. 6. History of head injury or stroke. 7. History of metal implants in the head (except dental fillings). 8. History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps. 9. History of migraines in the last six months. 10. History of drug or alcohol abuse. 11. Inadequate communication with examiner. 12. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it. 13. Inability to sign a consent form.

Additional Information

Official title Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
Description Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months. Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2 Ages: 50-85 Genders: both
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Brainsway.