Evidence map›Paper›PMID 31403948›Full record

Trial reportJournal of Alzheimer's disease : JAD2019

A Clinical Trial of Transcranial Electromagnetic Treatment in Alzheimer's Disease: Cognitive Enhancement and Associated Changes in Cerebrospinal Fluid, Blood, and Brain Imaging.

Gary Arendash, Chuanhai Cao, Haitham Abulaban, Rob Baranowski, Gary Wisniewski, Lino Becerra, Ross Andel, Xiaoyang Lin, Xiaolin Zhang, David Wittwer and 3 more

Open access · bronzeAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Alzheimer's disease : JAD, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
2.6field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 47 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 2 countries.

Gary ArendashNeuroEM Therapeutics, Inc., Phoenix, AZ, USA.
Chuanhai CaoCollege of Pharmacy, University of South Florida, Tampa, FL, USA.
Haitham AbulabanUniversity of South Florida Health/Byrd Alzheimer's Institute, Tampa, FL, USA.
Rob BaranowskiLeft Coast Engineering, Escondido, CA, USA.
Gary WisniewskiInvicro, Boston, MA, USA.
Lino BecerraInvicro, Boston, MA, USA.
Ross AndelSchool of Aging Studies, University of South Florida, Tampa, FL, USA.
Xiaoyang LinCollege of Pharmacy, University of South Florida, Tampa, FL, USA.
Xiaolin ZhangCollege of Pharmacy, University of South Florida, Tampa, FL, USA.
David WittwerOcotillo Electromagnetics, Inc., Chandler, AZ, USA.
Jay MoultonRF Exposure Laboratory, San Marcos, CA, USA.
John ArringtonUniversity Diagnostic Institute, Tampa, FL, USA.
Amanda SmithUniversity of South Florida Health/Byrd Alzheimer's Institute, Tampa, FL, USA.
University of South Florida · USInvicro (United States) · USCharles University · CZNeuroEM Therapeutics (United States) · USUniversity Diagnostic Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSmall aggregates (oligomers) of the toxic proteins amyloid-β (Aβ) and phospho-tau (p-tau) are essential contributors to Alzheimer's disease (AD). In mouse models for AD or human AD brain extracts, Transcranial Electromagnetic Treatment (TEMT) disaggregates both Aβ and p-tau oligomers, and induces brain mitochondrial enhancement. These apparent "disease-modifying" actions of TEMT both prevent and reverse memory impairment in AD transgenic mice.

objectiveTo evaluate the safety and initial clinical efficacy of TEMT against AD, a comprehensive open-label clinical trial was performed.

methodsEight mild/moderate AD patients were treated with TEMT in-home by their caregivers for 2 months utilizing a unique head device. TEMT was given for two 1-hour periods each day, with subjects primarily evaluated at baseline, end-of-treatment, and 2 weeks following treatment completion.

resultsNo deleterious behavioral effects, discomfort, or physiologic changes resulted from 2 months of TEMT, as well as no evidence of tumor or microhemorrhage induction. TEMT induced clinically important and statistically significant improvements in ADAS-cog, as well as in the Rey AVLT. TEMT also produced increases in cerebrospinal fluid (CSF) levels of soluble Aβ1-40 and Aβ1-42, cognition-related changes in CSF oligomeric Aβ, a decreased CSF p-tau/Aβ1-42 ratio, and reduced levels of oligomeric Aβ in plasma. Pre- versus post-treatment FDG-PET brain scans revealed stable cerebral glucose utilization, with several subjects exhibiting enhanced glucose utilization. Evaluation of diffusion tensor imaging (fractional anisotropy) scans in individual subjects provided support for TEMT-induced increases in functional connectivity within the cognitively-important cingulate cortex/cingulum.

conclusionTEMT administration to AD subjects appears to be safe, while providing cognitive enhancement, changes to CSF/blood AD markers, and evidence of stable/enhanced brain connectivity.

Indexed as

AgedAged, 80 and overAlzheimer DiseaseAmyloid beta-PeptidesCognitionFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedNeuroimagingNeuropsychological Teststau ProteinsTranscranial Magnetic StimulationTreatment OutcomeAmyloid beta-Peptidestau ProteinsAmyloid-βbrain electromagnetic wavescognitive enhancementFDG-PETfunctional MRI

Identifiers

PMID31403948
PMCPMC6839500
OpenAlexW2965895736

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.