ME/CFS Brain Fog: Cognitive Rehabilitation Trial

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akik ME/CFS-sel élnek, agyi köddel és gondolkodási nehézségekkel küzdenek, és részt tudnak venni az online képzésben és a laborlátogatásokon.

Életkor

18 éves vagy idősebb, felső korhatár nélkül, ha az egészségi állapot stabil.

Nem

Nemtől függetlenül bárki részt vehet.

A betegség stádiuma

A gondolkodási panaszok előtt diagnosztizált ME/CFS; legalább enyhe kognitív károsodás; legalább közepes agyi köd; a napi tevékenységekben van valamennyi nehézség.

Korábbi kezelés

Nem végezhetett korábban kognitív feldolgozási sebesség tréninget a DoubleDecision vagy hasonló programmal.

A részvétel fő kizáró okai

• A gondolkodási problémát más agyi állapot okozza, például fejlődési zavar, pszichiátriai betegség, szerhasználat, agysérülés, szélütés vagy Alzheimer-kór
• Pozicionális ortosztatikus tachycardia szindróma (POTS) diagnózisa
• Korábbi szívinfarktus vagy más súlyos szívprobléma; bármilyen beültetett orvosi eszköz
• Korábbi epilepsziás roham, epilepszia vagy ájulás (vazovagális szinkópé)
• Terhesség vagy szoptatás; nem tud vagy nem akar MRI-vizsgálatot vagy vérvételt vállalni

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

The purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.

A vizsgálat 2 csoportja

• CICT + taVNSA vizsgált kezelés

  Constraint-Induced Cognitive Therapy uses in-lab training on everyday activities with important cognitive components, along with the procedures designed to transfer improvements from the treatment setting to everyday life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation.

  Kezelés: Processing Speed Training, In-session Instrumental Activities of Daily Living Training, Transfer Package, Follow Up Phone Calls és Trans-auricular Vagus Nerve Stimulation: High Intensity

• BFT + taVNSMár használt kezelés, összehasonlításként

  Brain Fitness Training involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This will be combined with computer-based reaction time training and non-invasive vagus nerve stimulation.

  Kezelés: Transfer Package, Follow Up Phone Calls, In-session Brain Health Training, Reaction Time Training és Trans-auricular Vagus Nerve Stimulation: Low Intensity