Recruiting
Phase 1
Phase 2

LIWA

Sponsor:

American Society Of Thermalism And Climatology Inc

Code:

NCT02204969

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Lithia water

Transcranial Magnetic stimulation

Study Details

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

Study ID

NCT02204969

Start date

Jan, 2015

Status verified date

Jan, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 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 neuro stimulators, 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.
12. Leukemia

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Transcranial magnetic stimulation

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.

placebo comparator: lithia water

  • 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

Interventions

Lithia water

  • 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

Transcranial Magnetic stimulation

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.

Primary outcome measure

  • Cognitive functioning score by ADAS-COG [ Time Frame: 4 months ]

Central Contacts and Locations

Locations

Gaviota Clinic

Recruiting

Newark, New Jersey, United States, 07105

Contacts

Principal Investigator:

Garis Silega, Dr

More Information

Sponsor

American Society Of Thermalism And Climatology Inc

Last update posted

Jan 6, 2015

Last verified

Jan, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by American Society Of Thermalism And Climatology Inc on 2015-01-06.