NCT06134219: MF-Course

Course for Brain Fatigue After Graves' Disease Controlled Study

Recruiting now NA Last updated 21 November 2025

What this trial tests

NA trial testing MF course in Graves Disease in 96 participants. Currently enrolling.

Timeline

10 October 2023

Primary endpoint
10 July 2026

10 May 2027

Quick facts

Lead sponsor	Vastra Gotaland Region
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	10 October 2023
Primary completion	10 July 2026
Estimated completion	10 May 2027
Sites	1 location across Sweden

Drugs / interventions tested

• MF course
• Usual health care

Conditions studied

• Graves Disease — all drugs for Graves Disease →

Sponsor

Vastra Gotaland Region — full company profile →

Who can join

Adults 18 to 72, any sex, with Graves Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Brain fatigue in Graves' disease: symptoms and presentation of a possible mechanism at the cellular level.
   Tammelin K, Holmberg M, Lindo A, Johansson B, et al · · 2026 · PMID 41711390 · DOI 10.1530/etj-25-0172