Evidence map›Paper›PMID 35141396›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2021

Gamma-induction in frontotemporal dementia (GIFTeD) randomized placebo-controlled trial: Rationale, noninvasive brain stimulation protocol, and study design.

Martina Assogna, Giulia Sprugnoli, Daniel Press, Brad Dickerson, Joanna Macone, Sonia Bonnì, Ilaria Borghi, Ann Connor, Megan Hoffman, Nainika Grover and 8 more

Open access · goldAbstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 29% 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Frontotemporal Dementia, Where Do We Stand? A Narrative Review.International journal of molecular sciences · 2023
    Review
  7. Article
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

18 authors at 7 institutions in 3 countries.

Martina AssognaBerenson-Allen Center for Noninvasive Brain Stimulation Beth Israel Deaconess Medical Center Harvard Medical School Boston Massachusetts USA.
Giulia SprugnoliBerenson-Allen Center for Noninvasive Brain Stimulation Beth Israel Deaconess Medical Center Harvard Medical School Boston Massachusetts USA.
Daniel PressBerenson-Allen Center for Noninvasive Brain Stimulation Beth Israel Deaconess Medical Center Harvard Medical School Boston Massachusetts USA.
Brad DickersonFrontotemporal Disorders Unit and Alzheimer's Disease Research Center Departments of Psychiatry and Neurology Massachusetts General Hospital Boston Massachusetts USA.
Joanna MaconeBerenson-Allen Center for Noninvasive Brain Stimulation Beth Israel Deaconess Medical Center Harvard Medical School Boston Massachusetts USA.
Sonia BonnìNon-Invasive Brain Stimulation Unit Department of Behavioural and Clinical Neurology Santa Lucia Foundation IRCCS Rome Italy.
Ilaria BorghiNon-Invasive Brain Stimulation Unit Department of Behavioural and Clinical Neurology Santa Lucia Foundation IRCCS Rome Italy.
Ann ConnorBerenson-Allen Center for Noninvasive Brain Stimulation Beth Israel Deaconess Medical Center Harvard Medical School Boston Massachusetts USA.
Megan HoffmanBerenson-Allen Center for Noninvasive Brain Stimulation Beth Israel Deaconess Medical Center Harvard Medical School Boston Massachusetts USA.
Nainika GroverBerenson-Allen Center for Noninvasive Brain Stimulation Beth Israel Deaconess Medical Center Harvard Medical School Boston Massachusetts USA.
Bonnie WongFrontotemporal Disorders Unit and Alzheimer's Disease Research Center Departments of Psychiatry and Neurology Massachusetts General Hospital Boston Massachusetts USA.
Changyu ShenRichard and Susan Smith Center for Outcomes Research in Cardiology Division of Cardiology Beth Israel Deaconess Medical and Harvard Medical School Boston Massachusetts USA.
Alessandro MartoranaMemory Clinic System Medicine Department Tor Vergata Policlinic Rome Italy.
Molly O'ReillyBerenson-Allen Center for Noninvasive Brain Stimulation Beth Israel Deaconess Medical Center Harvard Medical School Boston Massachusetts USA.
Giulio RuffiniNeuroelectrics Corporation Barcelona Spain.
Georges El FakhriGordon Center for Medical Imaging Department of Radiology Massachusetts General Hospital Harvard Medical School Boston Massachusetts USA.
Giacomo KochNon-Invasive Brain Stimulation Unit Department of Behavioural and Clinical Neurology Santa Lucia Foundation IRCCS Rome Italy.
Emiliano SantarnecchiBerenson-Allen Center for Noninvasive Brain Stimulation Beth Israel Deaconess Medical Center Harvard Medical School Boston Massachusetts USA.
Beth Israel Deaconess Medical Center · USBerenson Allen Center for Noninvasive Brain Stimulation · USFondazione Santa Lucia · ITMassachusetts General Hospital · USDeaconess Hospital · USLight Prescriptions Innovators (Spain) · ESPoliclinico Tor Vergata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFrontotemporal dementia (FTD) is a neurodegenerative disorder for which there is no effective pharmacological treatment. Recently, interneuron activity responsible for fast oscillatory brain activity has been found to be impaired in a mouse model of FTD with consequent cognitive and behavioral alterations. In this study, we aim to investigate the safety, tolerability, and efficacy of a novel promising therapeutic intervention for FTD based on 40 Hz transcranial alternating current stimulation (tACS), a form of non-invasive brain stimulation thought to engage neural activity in a frequency-specific manner and thus suited to restore altered brain oscillatory patterns.

methodsThis is a multi-site, randomized, double-blind, placebo-controlled trial on 50 patients with a diagnosis of behavioral variant FTD (bvFTD). Participants will be randomized to undergo either 30 days of 1-hour daily tACS or Sham (placebo) tACS. The outcomes will be assessed at baseline, right after the intervention and at a 3- to 6-months follow-up. The primary outcome measures are represented by the safety and feasibility of tACS administration, which will be assessed considering the nature, frequency, and severity of adverse events as well as attrition rate, respectively. To assess secondary outcomes, participants will undergo extensive neuropsychological and behavioral assessments and fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans to evaluate changes in brain metabolism, functional and structural magnetic resonance imaging (MRI), resting and evoked electroencephalography, as well as blood biomarkers to measure changes in neurodegenerative and neuroinflammatory markers.

resultsThe trial started in October 2020 and will end in October 2023. Study protocols have been approved by the local institutional review board (IRB) at each data-collection site. DISCUSSION: This study will evaluate the safety and tolerability of 40 Hz tACS in bvFTD patients and its efficacy on gamma oscillatory activity, cognitive function, and brain glucose hypometabolism.

Indexed as

40 Hzbehavioral variantbrain stimulationbvFTDcontrolled clinical trialdementiaFDGfrontotemporal dementiaFTDgamma frequencyinhibitory interneuronssomatostatintACStranscranial alternating current stimulation

Identifiers

PMID35141396
PMCPMC8813035
OpenAlexW4210704617

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.