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Spatial NeglectPhase 2NCT01085903

Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

A Phase 2 study testing Modafinil, Baseline and CPS in people with Spatial Neglect and Dysphagia, run by University of Arkansas at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to examine how stroke can alter arousal, alertness, neglect and dysphagia, and whether a medication, modafinil, can improve arousal. Read more about this study

Who is it for?
Ages 19 to 85 years
Conditions the study is for
Spatial Neglect, Dysphagia
What is being tested?
Modafinil, Baseline and CPS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
2 sitesUnited States
Study dates
Mar 2010to Aug 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Willingness to complete study procedures
  • Ability to comprehend and sign informed consent
  • Evidence of unilateral, ischemic stroke based on:
  • Neuroimaging (clinically obtained imaging studies showing evidence of stroke)
  • Acceptable categories of stroke include:
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  • Unilateral ischemic stroke
  • Atherothrombotic stroke
  • Cardioembolic stroke
  • Lacunar stroke >1.5 cm
  • Chronic stable, unilateral hemorrhagic stroke
  • Or Behavioral evidence of stroke including:
  • Hemiplegia
  • Unilateral sensory impairment
  • Localized higher cortical dysfunction (e.g. neglect,dysphagia, apraxia)

Who cannot join

  • Cardiac valvular disease
  • Left heart hypertrophy
  • Poorly controlled hypertension
  • Active variant angina
  • Pre-menopausal women capable of having children, including those using active contraception (precaution for study medication and not applicable to normal subjects)
  • Severe renal or hepatic disease
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  • History of psychosis or substance abuse
  • Patients on other Central Nervous System (CNS) stimulants, dopamine agonists or antagonists (antipsychotics)
  • Severe speech comprehension deficit and/or inability to communicate responses
  • Allergies that could put the research subject at risk during the course of the study
  • Cannot speak English
  • Active cerebral neurologic disease other than stroke such as multiple sclerosis or Alzheimer's Disease
  • Active psychiatric illness except past history of treated depression or anxiety disorders
  • For persons needing an MRI - standard MRI exclusion criteria (cardiac pacemaker or defibrillator, artificial heart valves, metallic aneurysm clips eye or ear implants, implanted insulin or infusion pumps, battery activated stimulators, and history of claustrophobia)
  • Concomitant medications excluded: Based on recommendations of manufacturer, the following concomitant medications are excluded: Tricyclic antidepressants and Monoamine oxidase (MAO) inhibitors. Any other CNS stimulation producing medications. Antifungal agents Itraconazole or Ketoconazole as plasma concentrations of modafinil may be increased.
  • Stroke patients will be excluded from the modafinil trial if they cannot swallow a capsule.
  • Stroke patients are excluded if they are able to become pregnant
  • Any other criteria that the PI or study physicians feel would put the volunteer's health at risk during the course of the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Conway Regional Rehabilitation Hospital

    Conway, Arkansas, 72035

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

The purpose of this study is to examine how stroke can alter arousal, alertness, neglect and dysphagia, and whether a medication, modafinil, can improve arousal.

Read the detailed description

Neglect and dysphagia are two of the most problematic behavioral disorders encountered in stroke rehabilitation with 300,000 patients affected annually in the US. Both disorders impede progress in therapy and both lead to costly medical complications, like falls which are associated with neglect and aspiration pneumonia and malnutrition which are associated with dysphagia. No widely accepted pharmacological treatment exists for either disorder.

A new direction of this application is to view neglect and dysphagia as different disorders that share a common deficit in magnitude estimation (ME). ME refers to one's ability to perceive the intensity of sensory stimulation. Deficits in ME explain how much of a stimulus is neglected by stroke patients. Sensory deficits are also known to produce dysphagia. Perceptual deficits influence how patients response to stimuli like failing to act on all stimuli present (neglect) and failing to generate swallowing reflexes sufficient for normal bolus flow (dysphagia).

We know from previous work that ME is altered by change in cortical arousal following stroke (decreased or hypoarousal). Hypoarousal is evidenced by objective and subjective post-stroke fatigue and daytime sleepiness which occurs in 50% of stroke patients and can persist chronically. Increasing arousal could potentially reverse the perceptual deficits associated with hypoarousal and improve neglect and dysphagia. This proposal manipulates arousal in two ways. Cold pressor stimulation (CPS), immersing the foot in cold water for 50 seconds, is used to increase arousal and reverse neglect and dysphagia temporarily. A brief, 3-day trial of modafinil (Provigil) versus placebo is then used in stroke patients to learn if a positive response to cold-pressor stimulation can predicts patients who respond positively to modafinil.

Being tested
Modafinil, Placebo, Baseline, CPS, Post CPS
Keywords
Spatial Neglect, Dysphagia, Arousal, Modafinil, Stroke
Medical subject headings
Deglutition Disorders, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ModafinilDrug

    Also called Provigil

    200 mg once daily with morning meal for three days administered only to stroke patients

  • PlaceboDrug

    Also called inert

    Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

  • BaselineBehavioural

    Also called baseline observation

    Observations made at baseline before any intervention

  • CPSBehavioural

    Also called cold pressor stimulation

    Submerging each participant's foot into ice water (36-44 F) for 50 seconds.

  • Post CPSBehavioural

    Also called post cold pressor stimulation

    20 minutes following the CPS condition.

  • Follow upBehavioural

    Also called three month follow up

    Follow up testing occurred at 3 months

Study groups in NCT01085903
Study groupRoleWhat they receive
normal subjectsActive comparatorNormal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.
Receives: Behavioral: Baseline; Behavioral: CPS; Behavioral: Post CPS; Behavioral: Follow up
stroke subjectsActive comparatorStroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.
Receives: Drug: Modafinil; Drug: Placebo; Behavioral: Baseline; Behavioral: CPS; Behavioral: Post CPS; Behavioral: Follow up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. P50 Percent Habituation Score

    This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).

    Measured: baseline and after three days of intervention

Secondary outcomes (3)

  1. PVT Fastest 10 Percent of Reaction Times

    This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).

    Measured: baseline and after three days of intervention

  2. Power Function Exponent for Oral Bolus Estimation

    This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).

    Measured: baseline and after three days of intervention

  3. Time to Swallow Puree Food

    This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only).

    Measured: baseline and after three days of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01085903
Sponsor's protocol ID
110644
Other IDs
R21HD055677
Status last verified
Oct 2016
First submitted
9 Mar 2010
Last updated
18 Oct 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modafinil, Baseline and CPS in people with Spatial Neglect and Dysphagia, run by University of Arkansas at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

P50 Percent Habituation Score (time frame: baseline and after three days of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01085903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.

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