Clinical trial NCT00753662: Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
Official title: Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: TMS AD H2 coil
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Brainsway
First posted: 2008-09-16
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex 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.

Detailed description: Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17).

Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm.

Ages: 50-80 Genders: both

Eligibility criteria: Inclusion Criteria:

* Written informed consent will be obtained
* diagnostic evidence of probable AD consistent with DSM IV
* stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening
* stable dose treatment with other drugs
* MMSE \<25

Exclusion Criteria:

* Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD
* Patients who are unwilling or unable to fulfill the requirements of the study
* Severe personality disorder
* Malignant or untreated Hypertension
* History of Epilepsy
* History of Head trauma
* Metal implant in head, cardiac pacemaker, medical pump
* Drug or alcohol addiction
* Involvement in any other clinical trial during the preceding 3 month
* Patient who are unwilling or unable to give Informed Consent

Primary outcomes:
measure: ADAS-COG
timeFrame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
Secondary outcomes:
measure: CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.
timeFrame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center, Neurology Department
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Alissa Ash, Dr.
role: PRINCIPAL_INVESTIGATOR
References: