NCT06134219 Course for Brain Fatigue After Graves' Disease Controlled Study
| NCT ID | NCT06134219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Graves Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-10-10 |
| Primary Completion | 2026-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2023-10-10 with a primary completion date of 2026-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
BACKGROUND. Mental fatigue (MF) is common in the most common form of hyperthyroidism, Graves' disease (GD). Clinically, MF is the primary mental symptom in patients with GD and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and emotional lability. It may be the main contributing factor to the continued low quality of life in many patients with GD. MF can be measured with an MF score (MFS). The pathophysiology is unknown. There is no medical treatment, which requires patients to adapt to the situation. AIM. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue in GD, through an MF course as an addition to standard care, compared to patients who receive only standard care. The investigators also test the hypothesis that the MF course is a cost-effective intervention. METHOD. In a randomized controlled study, the investigators evaluate the effect of the MF course compared to standard care only in 96 patients with persistent MF in GD. Markers of mental health, QoL, and activity capacity are evaluated at baseline, 3, 6, and 12 months after intervention/inclusion. The primary outcome measure is MFS at 3 months. CLINICAL SIGNIFICANCE. Patients report feeling neglected by healthcare for decades, and healthcare professionals are frustrated by the lack of guidance. Patient organizations highlight the need for research; they want mental symptoms to be characterized as a consequence of thyroid disease, they demand biomarkers, specific treatments, and personalized care. Our research group is working to address the cause of MF in GD and also to alleviate the symptoms. The MF course may prove to be an important tool that can be quickly implemented in clinical practice, especially in primary care. Our involvement in regional/national working groups will facilitate implementation in other units. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue at GD, through an MF course as an addition to regular healthcare, compared to patients receiving only regular healthcare.
Eligibility Criteria
Inclusion Criteria: * 18-72 years old * 15-72 months since first Graves' diagnosis * high free thyroxin and thyroid antibodies (TRAb) at diagnosis * euthyroid the last 6 months normal thyroid hormone levels at inclusion * symptoms on MF in connection to Graves diagnosis * MF-scale ≥10.5 points Exclusion criteria: * other diseases or situations that may be associated with mental fatigue (such as other active inflammatory disease, neurological disease) * pregnancy * lactation * assessment that the patient cannot follow the study protocol.
Contact & Investigator
Helena Filipsson Nyström
PRINCIPAL INVESTIGATOR
Sahlgrenska Universitet sjukhus
Frequently Asked Questions
Who can join the NCT06134219 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 72 Years, studying Graves Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06134219 currently recruiting?
Yes, NCT06134219 is actively recruiting participants. Contact the research team at agneta.lindo@vgregion.se for enrollment information.
Where is the NCT06134219 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06134219 clinical trial?
NCT06134219 is sponsored by Vastra Gotaland Region. The principal investigator is Helena Filipsson Nyström at Sahlgrenska Universitet sjukhus. The trial plans to enroll 96 participants.