Subjective Cognitive ComplaintsCogSCCNCT07743229
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
A study testing COG+OT Telerehabilitation in people with Subjective Cognitive Complaints and Ehlers-Danlos Syndrome, run by Medical University of South Carolina at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Subjective Cognitive Complaints, Ehlers-Danlos Syndrome, Cognitive Dysfunction
- What is being tested?
- COG+OT Telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michelle Woodbury, PhD, OTR/L contact
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29412
Medical University of South Carolina
Charleston, South Carolina, 29425
Michelle L Woodbury, PhD
About this study
Official title: A Comprehensive Cognitive Assessment Protocol and Innovative Neurocognitive Telerehabilitation Pilot Program for Adults With Subjective Cognitive Complaints
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.
- Being tested
- COG+OT Telerehabilitation
- Keywords
- Subjective cognitive complaints, Brain fog, Functional cognition, Occupational therapy, Cognitive rehabilitation, Ehlers-Danlos Syndrome
- Medical subject headings
- Ehlers-Danlos Syndrome, Cognitive Dysfunction, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COG+OT TelerehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: COG+OT Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment to post-treatment, approximately 8 weeks
Secondary outcomes (2)
Retention Rate
Feasibility measured as the percentage of participants who complete all study sessions.
Measured: Through study completion, approximately 8 weeks
Adherence Rate
Feasibility measured as the percentage of participants completing intervention activities for each session, including functional task practice and homework.
Measured: Through study completion, approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive ComplaintsStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Woodbury, PhD, OTR/L, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743229
- Sponsor's protocol ID
- Pro00151173
- Acronym
- CogSCC
- Status last verified
- Nov 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Cognitive Assessment Protocol and Innovative Neurocognitive Telerehabilitation Pilot Program for Adults With Subjective Cognitive Complaints
- ClinicalTrials.gov ID
- NCT07743229
- Acronym / sponsor ID
- CogSCC / Pro00151173
- Keywords
- Subjective cognitive complaints, Brain fog, Functional cognition, Occupational therapy, Cognitive rehabilitation, Ehlers-Danlos Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Subjective Cognitive Complaints | Experimental | Behavioral: COG+OT TelerehabilitationCommunity-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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COG+OT TelerehabilitationCOG+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. | Behavioural | Adults With Subjective Cognitive Complaints |
Primary outcome
Change in Everyday Cognition Scale-II (ECog-II) Score
Time frame: Pre-treatment to post-treatment, approximately 8 weeks
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.
2 secondary outcomes
Retention Rate
Time frame: Through study completion, approximately 8 weeks
Adherence Rate
Time frame: Through study completion, approximately 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Woodbury, PhD, OTR/L contact
Michelle Woodbury, PhD, OTR/L principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COG+OT Telerehabilitation in people with Subjective Cognitive Complaints and Ehlers-Danlos Syndrome, run by Medical University of South Carolina 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Finetto, OTR/L (843-792-8533, piersonp@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Everyday Cognition Scale-II (ECog-II) Score (time frame: Pre-treatment to post-treatment, approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.