Transcranial Magnetic Stimulation (TMS) Treatment for Alzheimer Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

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

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.
    

Intervention name(s): TMS , H2-coil
Intervention type(s): Device
Intervention description(s): Trans cranial magnetic stimulation with H2-coil
Other intervention name(s): Not relevant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Improvement of ADAS-COG