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NCT05507138 · ClinicalTrials.gov registry record · Phase 2

A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

A Phase 2 study of Depression and Stroke, sponsored by Weill Medical College of Cornell University.

Recruiting
Registry status
Phase 2
Development phase
70
Enrollment target
1
Study location

NCT05507138: Recruiting Phase 2 study of Depression and Stroke, sponsored by Weill Medical College of Cornell University.

NCT05507138 is a Phase 2 study of Depression and Stroke that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 70 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05507138, a Phase 2 study of Depression and Stroke, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.

RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies. The hypotheses are that this treatment will improve cognitive skills, depression symptoms, daily function, and brain connectivity. In the short-term, the findings will inform the efficacy of the intervention and in the long-term, may support the use of the intervention to improve co-occurring cognitive and mood difficulties after stroke.

Primary Outcome

Change in score in the active intervention arm vs. the comparator arm on the SDMT, a performance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance.

Interventions

  • DEVICE AKL-T01
  • BEHAVIORAL Metacognitive Strategy Training

Study Locations (1)

New York

  • Weill Cornell Medical Center - New York

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2023-03-01
Est. Completion 2026-07-01
Phase Phase 2

What NCT05507138 shows while recruiting

NCT05507138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower).

The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which AKL-T01 is the first listed.

NCT05507138 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT05507138 about?

NCT05507138 is a clinical study titled "A Digital Intervention for Post-Stroke Depression and Executive Dysfunction". Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies. The hypotheses are that this tr...

What is the current status of trial NCT05507138?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2023-03-01. Estimated completion is 2026-07-01.

What conditions does trial NCT05507138 study?

This clinical trial studies the following conditions: Depression, Stroke, Executive Dysfunction.

What interventions are being tested in trial NCT05507138?

The interventions under investigation include: AKL-T01 (DEVICE), Metacognitive Strategy Training (BEHAVIORAL).

Who is sponsoring clinical trial NCT05507138?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05507138 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05507138's enrollment target sits among peer trials

70 407th of 679 higher than 266 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05507138, the US trial registry maintained by the National Library of Medicine. NCT05507138 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.