NCT07278206Toboroz
Brain Stimulation in Long COVID
Mitigating Cognitive Problems and Fatigue With Brain Stimulation in Long COVID
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 19.
Rövid összefoglaló (regiszter, angolul)
Cognitive problems and severe fatigue are two frequently occurring symptoms in long COVID, also known as Post-Covid Condition or Post-Acute Sequelae of COVID-19 (PASC), and their causes are currently unknown. Previous studies have shown reduced blood flow and increased inflammation in the brains of people with PASC. These brain processes are related to fatigue and cognitive problems. In other conditions, these disrupted brain processes have been treated safely and successfully with non-invasive brain stimulation. This may offer an effective treatment for people with PASC. The main goal of this clinical trial is to see whether non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS) can reduce fatigue in adults with PASC who also have trouble concentrating. rTMS uses short magnetic pulses on the scalp to gently stimulate a small brain area. In this study, 66 adults with PASC will be included, recruited through the Post-COVID Network Netherlands. Participants will be randomly assigned to receive either active rTMS or sham (placebo) rTMS. Sham rTMS feels and looks similar to the active treatment, but it does not generate effective magnetic pulses. The brain area that will be targeted is personalized using a brain scan (MRI) during a planning task. All participants will receive 24 rTMS sessions over six weeks (four per week). Fatigue will be measured within two weeks before and two weeks after treatment to determine whether active rTMS works better than sham. We will also look at cognition, brain connectivity and blood flow, signs of (neuro)inflammation, daily activity using an activity watch, and questionnaires about quality of life, mood, and sleep. Follow-up on cognition and questionnaires will take place 3 and 6 months after the end of the treatment.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 66 (tervezett)
- Első benyújtás
- 2025. nov. 19.
- Kezdés
- 2025. nov. 17.
- Elsődleges befejezés
- 2028. nov. 17.
- Fő szponzor
- Amsterdam UMC, location VUmc
- Betegségek
- Long COVID és ME/CFS
- NCT-szám
- NCT07278206
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 66
- 2025. nov. 17. és az elsődleges befejezés (2028. nov. 17.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Prior rTMS treatment or current intensive/experimental treatment for long COVID.
- Recent initiation or dosage change of psychotropic medication (less than six weeks for psychotropic medication including antidepressants and antipsychotic drugs, less than two weeks for benzodiazepines). Medication doses must remain stable during the study.
- Other active concurrent pharmacological treatments for post-covid symptoms
- Contraindications to MRI scanning (e.g., non-removable metallic implants, severe claustrophobia).
- Presence of a cochlear implant.
- High alcohol consumption (males/females: 21/14 units per week) or use of epileptogenic drugs.
Más betegség
- History of epilepsy or first-degree family history of epilepsy.
- Neurological disorders such as multiple sclerosis or other neurodegenerative conditions.
- Known brain lesions or ischaemic scars influencing seizure threshold.
- Severe cardiovascular disease
Egyéb
- Pregnancy.
- Severe uncontrolled migraines.
- Raised intracranial pressure.
- Severe sleep deprivation at the time of treatment.
Kiket keres a vizsgálat
- Meet the World Health Organization (WHO) definition of long COVID.
- Aged 18 years or older.
- Severe fatigue, defined as a score ≥35 on the Checklist Individual Strength (CIS) fatigue subscale.
- Significant cognitive complaints, defined as a score ≥18 on the CIS concentration subscale.
- Commitment to actively undergo rTMS
- Ability to attend the study site regularly for treatment sessions.
- Capacity to provide written informed consent.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Amsterdam UMC | Amsterdam | Hollandia | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.