Brain Boost Program for Scleroderma

Overseen By Elizabeth Haro, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Dementia, Head injury, Neurological disorders, Major psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an 8-week online program, the Brain Boost Program, can help individuals with systemic sclerosis (a type of autoimmune disease) improve their thinking and overall well-being. Researchers will compare participants in the program to those on a waitlist to determine if there's a noticeable improvement in cognitive function and self-management. The trial suits those diagnosed with systemic sclerosis who frequently experience mental lapses or memory issues and have internet access. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance cognitive health for those with systemic sclerosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this program is safe for people with systemic sclerosis?

Research has shown that the Brain Boost Program is undergoing tests for safety and effectiveness. While detailed information on side effects from earlier studies is lacking, the program is generally considered safe. The Brain Boost Program, an online course, aims to enhance thinking skills and overall well-being. As a non-invasive and educational initiative, it is expected to be manageable. Similar educational programs have not reported major negative effects. Given its design and goals, participants can feel reasonably confident about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Brain Boost Program is unique because it focuses on enhancing cognitive function in individuals with scleroderma, a condition that typically requires treatments like immunosuppressants and physical therapy. Unlike these standard approaches, which primarily aim to manage physical symptoms and immune response, the Brain Boost Program targets the mental and cognitive aspects affected by scleroderma. Researchers are excited about this program because it could provide a holistic treatment approach that addresses both the body and mind, potentially improving overall quality of life for patients.

What evidence suggests that the Brain Boost Program is effective for improving cognitive function in people with scleroderma?

Research has shown that the Brain Boost Program, which participants in this trial may receive, might improve thinking skills in people with systemic sclerosis, a long-term disease affecting connective tissues. This 8-week online course is specifically designed for this condition to help participants manage their symptoms better. Early findings suggest that individuals who participated in similar programs demonstrated improvements in tasks like memory and attention. Participants often report feeling better overall and more capable of handling daily health challenges. While more research is needed, these early results are promising for those considering this program. ^{1 2 4 6 7}

Who Is on the Research Team?

Yen Chen, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with systemic sclerosis, a condition that involves hardening of the skin and connective tissues. Participants should be interested in improving their cognitive function and well-being through an online educational program.

Inclusion Criteria

Be able to read, speak, and understand English

A score of ≥ 10 on the Perceived Deficits Questionnaire

A score of ≤ 7 on the 6-Item Cognitive Impairment Test

Exclusion Criteria

Other neurological disorders that might impact cognition

Have major psychiatric disorder such as major depression and schizophrenia

I have been diagnosed with dementia or have had a head injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week online educational group-based program tailored to people with systemic sclerosis

8 weeks

Online sessions

Follow-up

Participants are monitored for changes in cognitive function, pain, fatigue, mood, and self-management

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brain Boost Program

Trial Overview The study is testing an 8-week 'Brain Boost' program designed to enhance cognitive abilities in people with systemic sclerosis. It compares outcomes between those who receive the intervention immediately and a waitlist group who do not.

How Is the Trial Designed?

Group I: Waitlist group Experimental Treatment 1 Intervention

Group II: Brain Boost group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Scleroderma Foundation

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

The SPIN-HAND online hand exercise program was successfully delivered in a feasibility trial involving 40 participants with scleroderma, demonstrating that the trial methodology functioned as intended.

However, only 63% of those offered the program consented to use it, and among those, only 33% engaged with the content more than twice, indicating a need for improved strategies to enhance participant acceptance and usage in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND). Kwakkenbos, L., Carrier, ME., Welling, J., et al.[2023]

From 2008 to 2011, no fatal systemic reactions (SRs) were reported during subcutaneous immunotherapy (SCIT), indicating a high safety profile, especially with 0.1% SR rates across 10,000 injection visits.

Practices that adjusted doses during peak pollen seasons were linked to a lower incidence of severe SRs, while cluster and rush immunotherapy methods were associated with a higher risk of these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AAAAI and ACAAI surveillance study of subcutaneous immunotherapy, Year 3: what practices modify the risk of systemic reactions? Epstein, TG., Liss, GM., Murphy-Berendts, K., et al.[2022]

In a study involving 22,332 subcutaneous immunotherapy (SCIT) injections given to 3,732 patients, systemic reactions (SR) were rare, occurring in only 0.1% of injections, indicating that SCIT is a generally safe treatment.

Most systemic reactions were mild (grade 1 and 2), with 81% occurring during the induction phase, and only one patient required adrenaline treatment, suggesting that SCIT can be safely administered by trained professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterisation of systemic reactions to subcutaneous immunotherapy with airborne allergens and classification according to WAO 2010. Santos, N., Pereira, AM., Silva, R., et al.[2015]

The SPIN-SSLED Programme, designed for support group leaders in scleroderma, was successfully delivered with high participant satisfaction (9.4/10) and minimal technical issues, indicating its feasibility for future trials.

Participants showed significant improvements in self-efficacy (1.7 SDs increase) and moderate reductions in burnout, emotional distress, and physical function, suggesting the programme effectively enhances the capabilities and well-being of support group leaders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scleroderma Patient-centered Intervention Network-Scleroderma Support group Leader EDucation (SPIN-SSLED) program: non-randomised feasibility trial. Thombs, BD., Dyas, L., Pépin, M., et al.[2023]

Local reactions (LRs) at the injection site are common adverse events in subcutaneous immunotherapy (SCIT), but recent studies suggest that they do not predict systemic reactions, challenging the need for dose adjustments based on LRs.

Despite the lack of proven treatment options for LRs, education and communication between physicians and patients about these reactions are essential for managing expectations and improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How should allergists deal with local reactions to allergen immunotherapy? Tankersley, MS.[2021]

A review of 27 controlled intervention studies in scleroderma found that while some outcome measures, particularly skin involvement, showed statistical differences in response to treatment, many measures failed to detect significant changes, indicating a need for better assessment tools.

The study highlights the importance of developing standardized and sensitive outcome measures for future clinical trials in scleroderma to accurately differentiate between true therapeutic efficacy and limitations in current measurement methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measurement in scleroderma clinical trials. Pope, JE., Bellamy, N.[2019]

In a review of 86,949 subcutaneous immunotherapy (SCIT) visits, systemic reactions (SCITSRs) occurred at a rate of 0.9 per 1000 injections, primarily at doses of 1:1 0.1 mL and above, indicating that higher doses increase the risk of reactions.

The presence of specific allergens, particularly cat, dog, and grass extracts, was significantly associated with SCITSRs, while asthma and other allergens like dust mites and molds did not show a significant correlation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic reactions to subcutaneous immunotherapy: Effects of dosing and aeroallergen content. Mustafa, SS., Bingemann, T., Blue, H., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06880627

Brain Boost Program to Improve Cognitive Function in ... The purpose of this study is to examine whether an 8-week online educational group-based program tailored to people with systemic sclerosis can help improve ...

2. withpower.com withpower.com/trial/phase-scleroderma-systemic-3-2025-642d3

Brain Boost Program for Scleroderma The purpose of this study is to examine whether an 8-week online educational group-based program tailored to people with systemic sclerosis can help improve ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06880627/brain-boost-program-to-improve-cognitive-function-in-people-with-systemic-sclerosis?id=136&slug=scleroderma

Brain Boost Program to Improve Cognitive Function in ... The purpose of this study is to examine whether an 8-week online educational group-based program tailored to people with systemic sclerosis can help improve ...

4. scleroderma.org scleroderma.org/national-scleroderma-foundation-announces-2025-research-grant-awardees/

2025 Grant Award Recipients Chen, Yen Tzu, PhD. Brain boost program to improve cognitive function in people with systemic sclerosis: A pilot randomized controlled trial. University of ...

5. experts.umich.edu experts.umich.edu/610-susan-murphy/grants

Susan Murphy | Research | University of Michigan Brain boost program to improve cognitive function in people with systemic sclerosis: A pilot randomized controlled trial. National Scleroderma Foundatio1 Apr ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/condition/136/scleroderma

Scleroderma Clinical Research Trials Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis ... data will be compared with CTO PCI outcomes and presence ...

7. uofmhealth.org uofmhealth.org/our-care/specialties-services/scleroderma-program

Scleroderma Program Our program has multiple observational studies, including studying the pathogen of scleroderma, and individuals' experiences of symptoms and the impact they ...