Back to resultsDeep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
TMS, H coil
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 50-85.
- Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
- Scored below 24 on the MMSE.
- 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.
- Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
- Gave their oral and written consent to participate in the trial.
Exclusion criteria:
- An additional neurological or psychiatric disorder.
- Severe personality disorder.
- Uncontrolled hypertension.
- History of epilepsy, seizure, or heat convulsion.
- History of epilepsy or seizure in first degree relatives.
- History of head injury or stroke.
- History of metal implants in the head (except dental fillings).
- 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.
- History of migraines in the last six months.
- History of drug or alcohol abuse.
- Inadequate communication with examiner.
- Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
- Inability to sign a consent form.
Sites / Locations
- Merchav Clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
TMS, High Frequency
TMS, Low Frequency
Sham Stimulation
Arm Description
High Frequency TMS with H coil to prefrontal cortex
Low Frequency TMS to Prefrontal cortex
Sham TMS with H Coil on Prefrontal Cortex
Outcomes
Primary Outcome Measures
cognitive functioning score by ADAS-COG
Secondary Outcome Measures
Global advancement score by CGI-C
Frontal lobe functioning score by FAB
Daily activity score by ADL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01179373
Brief Title
Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
Official Title
Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brainsway
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TMS, High Frequency
Arm Type
Active Comparator
Arm Description
High Frequency TMS with H coil to prefrontal cortex
Arm Title
TMS, Low Frequency
Arm Type
Active Comparator
Arm Description
Low Frequency TMS to Prefrontal cortex
Arm Title
Sham Stimulation
Arm Type
Placebo Comparator
Arm Description
Sham TMS with H Coil on Prefrontal Cortex
Intervention Type
Device
Intervention Name(s)
TMS, H coil
Other Intervention Name(s)
TransCranial Magnetic Stimulation
Intervention Description
TMS, H Coil, High/ Low Frequency
Primary Outcome Measure Information:
Title
cognitive functioning score by ADAS-COG
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Global advancement score by CGI-C
Time Frame
4 months
Title
Frontal lobe functioning score by FAB
Time Frame
4 months
Title
Daily activity score by ADL
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged 50-85.
Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
Scored below 24 on the MMSE.
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.
Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
Gave their oral and written consent to participate in the trial.
Exclusion criteria:
An additional neurological or psychiatric disorder.
Severe personality disorder.
Uncontrolled hypertension.
History of epilepsy, seizure, or heat convulsion.
History of epilepsy or seizure in first degree relatives.
History of head injury or stroke.
History of metal implants in the head (except dental fillings).
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.
History of migraines in the last six months.
History of drug or alcohol abuse.
Inadequate communication with examiner.
Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
Inability to sign a consent form.
Facility Information:
Facility Name
Merchav Clinics
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
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Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
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