Transcranial Magnetic Stimulation (TMS) Treatment for Alzheimer Patients

February 28, 2023 updated by: Hadassah Medical Organization

Deep-TMS for the Treatment of Alzheimer Disease Patients

Transcranial Magnetic Stimulation (TMS) for treatment of Alzheimer disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transcranial Magnetic Stimulation (TMS) for treatment of Alzheimer disease.

Alzheimer's disease (AD) is the leading cause of dementia and cognitive deteriorating in the advanced age. The current medical treatment of AD is mainly symptomatic and has many limitation. This main target of this study is to determine the safety and efficacy of transcranial magnetic stimulation (TMS) using novel coil design (H2) for stimulation of deep brain structures concomitantly with regular treatment in Alzheimer's disease (AD) patients. TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal activity translating into increased secretion of growth factors such as brain derived neurotrophic factor (BDNF). Hence it is postulated that TMS will have a positive effect on the cognitive and behavioral symptoms of patients with AD and may ameliorated the progression of the disease. The treatment is non-invasive, with no significant side effects, and no need of hospitalization or anesthesia. The trial is phase IIb double blind study including 45 AD patients ages between 50 to 80 with mild or moderate AD (Mini Mental State Examination [MMSE] between 16 to 26) divided into 3 groups. All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and than 1 treatment per week for additional 4 weeks. Patients will be evaluated before the treatments, after 8 weeks of treatment and after another 8 weeks without treatment. The evaluations will include cognitive function according to ADAS-COG and MMSE, Activity of daily living (ADL) functions according to ADSC-ADL, behavioral function according to the Neuropsychiatric Inventory (NPI), depression according to the Cornell Scale for Depression in Dementia (CSDD), care giver satisfaction according to the RUD LITE scale and computerized cognitive evaluation according to the NEXING battery. We expect that the cognitive, behavioral and ADL functions will improve better in the study group as compared to the Sham treated group. From previous trial of TMS in neurological patients, although not in AD, we anticipate that adverse events rate will be similar between groups proving the safety of deep TMS treatment in patients with AD. In case our hypothesis will be proven, deep TMS treatment will be added as an important modality to the conventional therapy of AD patients.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem District, Israel, 91120
        • Hadassah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women aged 50-85.
  2. Diagnosed with Alzheimer's disease for at least half a year (by the DSM-IV criteria).
  3. Scored between 16-26 on the MMSE.
  4. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks.
  5. Existence of a routine therapist for changes or adverse effects reports.
  6. Existence of Alzheimer diagnosis by CT or MRI tests.
  7. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
  8. Gave their oral and written consent to participate in the trial.

Exclusion Criteria:

  1. An additional neurological disorder.
  2. Severe psychiatric disorder.
  3. Uncontrolled hypertension, beyond 170/110.
  4. History of epilepsy, seizure, or heat convulsion or History of epilepsy or seizure in first degree relatives.
  5. History of head injury or stroke.
  6. History of metal implants in the head (except dental fillings)or 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.
  7. History of migraines in the last six months.
  8. History of drug or alcohol abuse.
  9. Inadequate communication with examiner.
  10. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
  11. Inability to sign a consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Frequency TMS to prefrontal cortex
Device: TMS , H2-coil
Trans cranial magnetic stimulation with H2-coil
Other Names:
  • Not relevant
Active Comparator: Low Frequency TMS to Prefrontal cortex
Device: TMS , H2-coil
Trans cranial magnetic stimulation with H2-coil
Other Names:
  • Not relevant
Sham Comparator: Sham TMS on Prefrontal Cortex
Device: TMS , H2-coil
Trans cranial magnetic stimulation with H2-coil
Other Names:
  • Not relevant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cognitive functioning score by ADAS-COG
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Zeev Meiner, Dr., Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0316 (Other Identifier: Klein Buendel, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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