Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease (TMS in AD)

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2

Conditions: Alzheimer's Disease

Treatments: Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex; Device: 1Hz TMS with H2 coil; Device: SHAM TMS with H2 coil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00753662

TASMC-08-AA-0397-CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

1

Active Comparator group

Description:

15 patients in group 1 will be treated with 1Hz frequency

Treatment:

Device: 1Hz TMS with H2 coil

2

Active Comparator group

Description:

15 patients in group 2 will be treated with 1Hz frequency 10Hz

Treatment:

Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex

3

Sham Comparator group

Description:

15 patients in group 3 will be treated with SHAM (1Hz/10Hz)

Treatment:

Device: SHAM TMS with H2 coil