Recruiting PHASE2 Fatigue

New treatment option for Fatigue

Official title Transcranial Direct Current Stimulation for Post-stroke Fatigue

ClinicalTrials.gov ID: NCT05816603

What this study is testing

What it's testing
The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Male or female patients aged \>18 years
  • Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).
  • Fatigue severity score average \>4 (severe fatigue)
  • Willingness to remain stable on pharmacologic therapy through the duration of the study.
  • Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.

You likely can't join if

  • Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)
  • History of seizure
  • History of moderate to severe traumatic brain injury
  • A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.
  • A score of less than 21 on the MoCA suggesting major neurocognitive disorder.
  • Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.
See the full eligibility criteria
Who can join
  • Male or female patients aged \>18 years
  • Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).
  • Fatigue severity score average \>4 (severe fatigue)
  • Willingness to remain stable on pharmacologic therapy through the duration of the study.
  • Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.
What rules you out
  • Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)
  • History of seizure
  • History of moderate to severe traumatic brain injury
  • A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.
  • A score of less than 21 on the MoCA suggesting major neurocognitive disorder.
  • Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.
  • Inability to provide informed consent
  • Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.

The study team makes the final eligibility decision.

Where it's taking place

  • New York, New York, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.