Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— TMS in AD  

Official title:

Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00753662
• Other study ID #: TASMC-08-AA-0397-CTIL
• Status: Recruiting
• Phase: Phase 2
• First received: September 14, 2008
• Last updated: September 12, 2011
• Start date: November 2008
• Est. completion date: November 2012

Study information

• Verified date: September 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Alissa Ash, Dr.
• Phone: +972-3-6973698
• Email: elissaa[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center, Neurology Department	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Brainsway

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-COG		Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)	Yes
Secondary	CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.		Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)	Yes