Phase 2 Stroke Trial, Recruiting NCT06638944 Sponsor: Purdue University Condition: Stroke
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Phase 2 Stroke Trial, Recruiting

NCT06638944
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People between 50 and 90 years old
  • People who have had a stroke confirmed by a neurologist or doctor, at least 3 months after the stroke occurred, or people diagnosed with Parkinson's disease at a moderate to more advanced stage (Hoehn and Yahr Stages II–IV)
  • People whose memory and thinking abilities fall in the normal to mild range, as measured by a standard screening test (called the MoCA) done at the trial site
  • People confirmed to have swallowing difficulties affecting the throat area, as assessed by a qualified Speech Language Pathologist (SLP) during an eligibility assessment
  • People who are able to perform the required swallowing exercises accurately enough, as assessed by a qualified SLP during an eligibility assessment
  • People who are able to use the trial's device (called the i-Phagia system) on their own or with help from a caregiver, after a training session, as assessed by a qualified SLP

Who may not be able to join:

  • People with a known allergy to barium, or a known or suspected blockage or perforation in the digestive tract
  • People who have had pneumonia in the past 6 months
  • People who have had surgery, radiation treatment, or significant injury to the head or neck
  • People whose memory and thinking abilities fall in the moderate-to-severe impairment range on the MoCA screening test
  • People with other neurological or neuromuscular conditions, such as multiple sclerosis, a brain tumour, or myositis
  • People who show difficulty following instructions due to neuropsychological issues identified during the in-house screening
  • People who are currently receiving swallowing or speech therapy
  • People with facial hair under the chin who are not willing to shave it
  • People with known allergies to Ten20® Conductive Paste (a paste used to help sensors stick to and read signals from the skin) or to the sensor materials (gold or acrylic) that contact the skin
  • People who are found not to have swallowing difficulties in the throat area, as assessed by a qualified SLP
  • People who are unable to perform the required exercises accurately after up to 12 practice attempts, as assessed by a qualified SLP
  • People who are unable to use the i-Phagia device accurately after training, as assessed by a qualified SLP
  • People who are unable to swallow at least one food or liquid consistency safely without inhaling it into the airway, as assessed by a qualified SLP

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Georgia Malandraki, PhD, Purdue University

Phone: 765-496-0207

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Purdue University
Registry
ClinicalTrials.gov
Start date
22 July 2025
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Penetration-Aspiration Scale (PAS); Functional Oral Intake Scale (FOIS); Normalized sEMG amplitude

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov