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

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
1Hz TMS with H2 coil
10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
SHAM TMS with H2 coil
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring TMS AD H2 coil

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tel Aviv Sourasky Medical Center, Neurology DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

ADAS-COG

Secondary Outcome Measures

CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.

Full Information

First Posted
September 14, 2008
Last Updated
September 12, 2011
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Brainsway
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1. Study Identification

Unique Protocol Identification Number
NCT00753662
Brief Title
Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Brainsway

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
TMS AD H2 coil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
15 patients in group 1 will be treated with 1Hz frequency
Arm Title
2
Arm Type
Active Comparator
Arm Description
15 patients in group 2 will be treated with 1Hz frequency 10Hz
Arm Title
3
Arm Type
Sham Comparator
Arm Description
15 patients in group 3 will be treated with SHAM (1Hz/10Hz)
Intervention Type
Device
Intervention Name(s)
1Hz TMS with H2 coil
Intervention Description
1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
Intervention Type
Device
Intervention Name(s)
10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
Other Intervention Name(s)
10Hz TMS with H2 coil
Intervention Description
10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
Intervention Type
Device
Intervention Name(s)
SHAM TMS with H2 coil
Intervention Description
SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex
Primary Outcome Measure Information:
Title
ADAS-COG
Time Frame
Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
Secondary Outcome Measure Information:
Title
CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.
Time Frame
Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alissa Ash, Dr.
Phone
+972-3-6973698
Email
elissaa@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alissa Ash, Dr.
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center, Neurology Department
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alissa Ash, Dr.
Phone
972-3-6973698
Email
elissaa@tasmc.health.gov.il

12. IPD Sharing Statement

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Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

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