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

Trial Summary

What is the purpose of this trial?

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 cognitive function and well-being. The study team hypothesize that participants that receive the intervention will have better improvements immediately after treatment at week 8 in all cognitive function measures, non-cognitive symptoms, and self-management compared to those in the waitlist control.

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 data supports the effectiveness of the Brain Boost Program treatment for scleroderma?

The research does not provide direct evidence for the effectiveness of the Brain Boost Program for scleroderma, but it highlights the importance of patient education and exercise programs, like the SPIN-HAND, which have been developed to improve hand function in scleroderma patients. ^{1 2 3 4 5}

Is the Brain Boost Program for Scleroderma safe for humans?

The research on subcutaneous immunotherapy (SCIT), which may be related to the Brain Boost Program, shows that while systemic reactions (body-wide responses) are rare, they can be serious. Local reactions (swelling at the injection site) are common but not usually severe. ^{6 7 8 9 10}

How is the Brain Boost Program treatment for scleroderma different from other treatments?

The Brain Boost Program for scleroderma is unique because it focuses on a comprehensive educational approach, involving a multi-professional team and patient interaction, rather than traditional drug treatments. This program is designed to empower patients through education and support, which is different from typical medical or exercise-based interventions. ^{1 4 11 12 13}

Research Team

Yen Chen, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Patient education "systemic sclerosis"]. [2007]

2. Canada pubmed.ncbi.nlm.nih.gov

Sample size calculations in scleroderma: a rational approach to choosing outcome measurements in scleroderma trials. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Outcome measurement in scleroderma clinical trials. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Skin involvement as a relevant outcome measure in clinical trials of systemic sclerosis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

AAAAI and ACAAI surveillance study of subcutaneous immunotherapy, Year 3: what practices modify the risk of systemic reactions? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

How should allergists deal with local reactions to allergen immunotherapy? [2021]

8. Singapore pubmed.ncbi.nlm.nih.gov

Characterisation of systemic reactions to subcutaneous immunotherapy with airborne allergens and classification according to WAO 2010. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Systemic reactions to subcutaneous immunotherapy: Effects of dosing and aeroallergen content. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Safety and treatment compliance of subcutaneous immunotherapy: A 30-year retrospective study. [2022]

11. China pubmed.ncbi.nlm.nih.gov

Follow-up efficacy of integrative Chinese and Western drugs on localized scleroderma with vitamine B6 and Xuefu Zhuyu decoction. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The effect of paraffin and exercise on hand function in persons with scleroderma: a series of single case studies. [2009]

13. England pubmed.ncbi.nlm.nih.gov

Scleroderma Patient-centered Intervention Network-Scleroderma Support group Leader EDucation (SPIN-SSLED) program: non-randomised feasibility trial. [2023]