LIWA for Treatment of Alzheimer Patients

NCT02204969 | Unknown Phase 1 DMC

• 1 other identifier: 822429989
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The thermal therapy combined with magnetic fields and ozone has a direct effect on patients with dementia and Alzheimer's with a regression of more than 60% of them

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Cognitive functioning score by ADAS-COG

  4 months

Study Arms (2)

Transcranial magnetic stimulation

SHAM COMPARATOR

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 then 1 treatment per week for additional 4 weeks.

Device: Transcranial Magnetic stimulation

lithia water

PLACEBO COMPARATOR

* Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water * Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels

Dietary Supplement: Lithia water

Interventions

Lithia water DIETARY_SUPPLEMENT

* Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water * Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels

Also known as: pring Mineral water

lithia water

Transcranial Magnetic stimulation DEVICE

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 then 1 treatment per week for additional 4 weeks.

Also known as: novel coil design (H2)

Transcranial magnetic stimulation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 50-85.
• Diagnosed with Alzheimer's disease for at least half a year (by the DSM-IV criteria).
• Scored 16-26 on the MMSE.
• Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks.
• Existence of a routine therapist for changes or adverse effects reports.
• Existence of Alzheimer diagnosis by CT or MRI tests.
• 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.

You may not qualify if:

• An additional neurological disorder.
• Severe psychiatric disorder.
• Uncontrolled hypertension, beyond 170/110.
• History of epilepsy, seizure, or heat convulsion or 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)or History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neuro stimulators, 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.
• Leukemia

Sponsors & Collaborators

• American Society Of Thermalism And Climatology Inc: lead

Study Sites (1)

Gaviota Clinic

Newark, New Jersey, 07105, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Garis Silega, Dr

  American Society of Thermalism and Climatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 31, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

US (1)