NCT07743229

Brief Summary

This pilot study will evaluate a comprehensive cognitive assessment approach and personalized neurocognitive telerehabilitation intervention for adults with subjective cognitive complaints (SCC). The study includes older adults with SCC and adults with Ehlers-Danlos Syndrome (EDS) and SCC. Participants will complete pre- and post-treatment assessments and receive a 6-week COG+OT telerehabilitation intervention that combines cognitive rehabilitation and occupational therapy strategies to support everyday functional cognition.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jul 2027

First Submitted

Initial submission to the registry

July 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

September 21, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

July 29, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

Subjective cognitive complaintsBrain fogFunctional cognitionOccupational therapyCognitive rehabilitationEhlers-Danlos Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in Everyday Cognition Scale-II (ECog-II) Score

    Change in subjective cognition measured using the Everyday Cognition Scale-II (ECog-II), a self-report measure assessing perceived cognitive functioning across everyday activities, including memory, executive function, language, and attention.

    Pre-treatment to post-treatment, approximately 8 weeks

Secondary Outcomes (2)

  • Retention Rate

    Through study completion, approximately 8 weeks

  • Adherence Rate

    Through study completion, approximately 8 weeks

Study Arms (1)

Adults With Subjective Cognitive Complaints

EXPERIMENTAL

Community-dwelling adults aged 60 years or older or Adult with Elhers Danlos Syndrome with subjective cognitive complaints who receive the 6-week COG+OT telerehabilitation intervention and complete pre- and post-treatment cognitive and functional assessments.

Behavioral: COG+OT Telerehabilitation

Interventions

COG+OT is a personalized telerehabilitation program that combines cognitive rehabilitation and occupational therapy. Cognitive rehabilitation sessions focus on strategies for attention, memory, organization, planning, problem solving, and executive function. Occupational therapy sessions use meaningful daily activities to support application and generalization of cognitive strategies in home- and community-based tasks. The intervention is delivered remotely over 6 weeks in 10 sessions lasting approximately 45 to 60 minutes each.

Adults With Subjective Cognitive Complaints

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endorsement of subjective cognitive complaints as indicated by a score ≥4 on the Healthy Brain 9 (HB9)
  • Community-dwelling adult aged 60 years or older, or adult aged 21 years or older with a diagnosis of Ehlers-Danlos Syndrome (EDS)
  • English as the primary language
  • Access to and ability to use a smartphone compatible with the NeuroUX platform
  • Access to a device capable of supporting a telerehabilitation visit, such as a phone, tablet, or laptop, and a reliable Wi-Fi or cellular internet connection
  • Able to participate in study assessment sessions as determined by the licensed, experienced telerehabilitation occupational therapist

You may not qualify if:

  • Diagnosis of dementia or mild cognitive impairment
  • Significant or unstable conditions or treatments for medical conditions that may impact cognition, such as traumatic brain injury or brain tumor
  • Inability to engage in study-related procedures as determined by the study team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29412, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Ehlers-Danlos SyndromeCognitive DysfunctionMental Fatigue

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesCognition DisordersNeurocognitive DisordersMental DisordersFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Michelle Woodbury, PhD, OTR/L

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Finetto, OTR/L

CONTACT

Michelle Woodbury, PhD, OTR/L

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michelle Woodbury, PhD, OTR/L, FAOTA

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 3, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

September 21, 2026

Record last verified: 2026-07

Locations