Evidence map›Paper›PMID 27534856›Full record

Trial reportTrials2016

Modafinil In Debilitating fatigue After Stroke (MIDAS): study protocol for a randomised, double-blinded, placebo-controlled, crossover trial.

Thomas Lillicrap, Venkatesh Krishnamurthy, John Attia, Michael Nilsson, Christopher R Levi, Mark W Parsons, Andrew Bivard

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.5field-weighted citation impact, top 12% 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

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Review
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

7 authors at 2 institutions in 1 country.

Thomas LillicrapDepartments of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia.
Venkatesh KrishnamurthyDepartments of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia.
John AttiaHunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia.
Michael NilssonHunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia.
Christopher R LeviDepartments of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia.
Mark W ParsonsDepartments of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia.
Andrew BivardDepartments of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia. Andrew.bivard@hotmail.com.
Hunter Medical Research Institute · AUJohn Hunter Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFatigue is a common symptom in stroke survivors for which there is currently no proven therapy. Modafinil is a wakefulness-promoting agent with established benefits in other disease models. We aim to test if modafinil will improve patient's self-reported fatigue scores when compared to placebo and if therapy results in increased quality of life. METHODS/

designMIDAS is a phase II, single-centre, prospective, double-blinded, randomised, crossover trial of modafinil for the treatment of persistent fatigue in survivors of ischaemic stroke. The inclusion criteria will require an average score of 12 or more across all domains of the Multi-dimensional Fatigue Inventory (MFI-20) and the diagnosis of a stroke more than 6 months prior. Patients will be randomised 1:1 to receive either modafinil 200 mg daily or placebo for a period of 6 weeks, after which a crossover will occur where patients who are on modafinil will begin taking placebo and vice versa. The primary outcome will be improvement in fatigue as measured by the MFI-20. Secondary outcomes will include changes in the Fatigue Severity Scale, improved cognition measured using the Montreal Cognitive Assessment, improvement in mood as determined by the Depression, Anxiety and Stress Scale and improvement in each patient's stroke-specific quality of life score. All participants will also undergo magnetic resonance imaging (MRI) at baseline, crossover and study conclusion to measure cerebral blood flow on arterial spin labelling and brain activity on resting state functional MRI. This study will comply with the CONSORT guidelines. The projected sample size requirement is 36 participants in a crossover trial giving a power of 80 % and a type-1 error rate of 0.05. DISCUSSION: MIDAS seeks to enhance the quality of life in stroke survivors by assisting or resolving stroke-associated fatigue.

trial registrationACTRN12615000350527 , registered on the 17 April 2015. Protocol version 3, approved 16 June 2015.

Indexed as

AffectBenzhydryl CompoundsClinical ProtocolsCognitionCross-Over StudiesDouble-Blind MethodFatigueHumansMagnetic Resonance ImagingModafinilNew South WalesProspective StudiesQuality of LifeRecovery of FunctionResearch DesignSeverity of Illness IndexBenzhydryl CompoundsModafinilWakefulness-Promoting AgentsFatigueIschaemic strokeStroke recovery

Identifiers

PMID27534856
PMCPMC4989372
OpenAlexW2513734416

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.