Clinical trial NCT06774287: Evaluation of the Karman Line Memory Strategy Training
Official title: Evaluation of the Karman Line Memory Strategy Training, a Combined Computerized and Face-to-face Compensatory Treatment Targeting Memory Complaints After Acquired Brain Injury, Using Single-case Experimental Design Methodology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acquired Brain Injury (including Stroke)
Keywords: Compensatory brain games
Acquired Brain Injury
memory disorder
Lead sponsor: Klimmendaal Revalidatiespecialisten
Sponsor class: NETWORK
First posted: 2025-01-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rationale: Acquired brain injury (ABI) often results in memory deficits that can have a big impact on social and vocational functioning of patients. Rehabilitation treatment of memory dysfunction consists of optimizing memory performance by using effective compensation strategies. Several effective memory-strategy training programs have been developed. However, these often contain labor-intensive treatment protocols that are possibly an overtreatment of ABI patients with relatively mild memory impairments. On the other hand there is a sprawl of commercial computerized cognitive training programs or 'brain games' available that claim to restore memory function. However, research has repeatedly shown that treatment effects of available brain games do not generalize to daily life functioning. With the shortcomings of current memory treatment programs in mind, the investigators developed a combined computerized and face-to-face training of memory strategies, which consists of a shortened traditional face-to-face treatment combined with an innovative Brain Game based on compensation strategies instead of restorative training. This is a promising cost-effective intervention that provides the possibility of repeated practice at home to train compensatory strategies in a safe and imaginative digital environment. The hypothesis is the strategy training will promote generalization, also after rehabilitation ends.

Objective: The primary objective is the evaluation of the potential positive effect of the combined computerized and face-to-face memory treatment on effective memory strategy use and reducing subjective memory failures in ABI patients with memory deficits in the chronic phase of acquired brain injury (\>3 months after injury).

Study design: The study will be a multiple-baseline across individuals single-case experimental design (SCED). Three patients will receive treatment as usual and three patients will receive a shortened treatment combined with the game, which will be referred to as the 'Karman Line memory strategy training'.

Study population: The study population consists of patients referred for outpatient cognitive rehabilitation. Participants eligible for the study must have memory deficits and complaints due to Acquired Brain Injury (ABI) of nonprogressive nature (i.e. TBI, stroke), with a minimum time post-onset of 3 months. Age has to be between 18 and 75 and participants have to live independently at home. Memory deficits will be assessed by neuropsychological examination, memory complaints will be assessed by the Everyday Memory Questionnaire-Revised (EMQ-R). In one year six to eight participants will be recruited.

Intervention: The Karman Line memory strategy training consists of six weekly treatment sessions under the guidance of a therapist. The protocol is a shortened version of an existing memory strategy training (treatment as usual), which contains ten sessions. In the sessions, patients get information about memory and memory strategies and learn to apply those to their personal treatment goals. Inbetween the sessions, the participant will work on personal memory goals and practice the strategies by playing the corresponding levels of the memory game at home.

Main study parameters/endpoints: The main study parameter is the three most commonly reported memory complaints selected from the 13-item scale of the EMQ-R. The primary outcome measure is not the EMQ-R, but a personalized set of measurement VAS-scales for each patient. Secondary study parameters include the impact of memory problems on activities and participation, the achievement of personalized treatment goals, objective strategy use, objective memory functioning, metacognitions about memory and measures of feasibility by patients and practitioners.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden in the study consists of participating in repeated measurements, therapy sessions, and homework assignments. All tests and methods that are used are non-invasive and not stressful for the patient. All tests and tasks will be based on widely-used validated and reliable paper-pencil or computer tasks. Treatment is non-invasive and scarcely stressful: a therapist will always be present and assess the patient's burden and eventually take appropriate measures such as inserting a resting break.


Eligibility criteria: Inclusion criteria:

* presence of subjective memory complaints. Memory complaints will be operationalized as ≥1 standard deviation on the total score of the EMQ-R questionnaire in comparison with the healthy control norm.
* presence of mild to moderate objective memory deficits, objectified with neuropsychological assessment for clinical purposes. Mild to moderate memory deficits will be operationalized as test score ≥1 standard deviation (SD) and \<2 SD in comparison to the normative mean on at least two separate memory measures and no more than one measure ≥ 2SD. For each task the norm data that is described in the test manual will be used.
* Age: 18-75 years
* Non-progressive acquired brain injury
* Minimal time post-onset of 3 months
* Outpatient rehabilitation
* Living independently at home
* Premorbid functioning: score 4 on the Verhage scale

Exclusion criteria:

* Severe memory deficits
* Inability to speak and/or understand the Dutch language
* Severe disorders in executive functioning
* Severe psychiatric problems
* Neurodegenerative disorders
* Substance abuse
* Aphasia
* Neglect
* No access to a smartphone and a tablet/laptop with internet connection
* Unable to look at a computer screen for 15 minutes
* Unable to operate a keyboard or computer mouse.
* No informed consent

Primary outcomes:
measure: memory complaints
timeFrame: every other day during 8-10 weeks, weekly during 3-5 weeks
Secondary outcomes:
measure: The impact of memory problems on activities and participation
timeFrame: every other day during 8-10 weeks, weekly during 3-5 weeks
measure: The achievement of personalized treatment goals
timeFrame: 4 measurements during study participation (during 13 weeks)
measure: Objective strategy use task
timeFrame: 4 measurements during study participation (during 13 weeks)
measure: Rivermead Behavioural Memory Test-3 (RBMT-3-NL)
timeFrame: 2 measurements during study participation (during 13 weeks)
measure: Location Learning Test (LLT)
timeFrame: 2 measurements during study participation (during 13 weeks)
measure: Verbal learning and memory test (VLGT).
timeFrame: 2 measurements during study participation (during 13 weeks)
measure: Delis-Kaplan Executive Function System Color Word Interference Test (D-KEFS CWIT)
timeFrame: 2 measurements during study participation (during 13 weeks)
measure: Wechsler Memory Scale IV-NL Symbol span
timeFrame: 2 measurements during study participation (during 13 weeks)
measure: Wechsler Adult Intelligence Scale IV-NL digit span (WAIS-IV-NL DS)
timeFrame: 2 measurements during study participation (during 13 weeks)
measure: Cognitive Failure Questionnaire (CFQ)
timeFrame: 4 measurements during study participation (during 13 weeks)
measure: Strategy Use in daily life Inventory (SUI)
timeFrame: 4 measurements during study participation (during 13 weeks)
measure: Adapted Illness Cognition Questionnaire (ICL)
timeFrame: 4 measurements during study participation (during 13 weeks)
measure: Measure of feasibility by patients and practitioners 1: qualitative questionnaire
timeFrame: 1 measurement during study participation (during 13 weeks)
measure: Measure of feasibility by patients and practitioners 2: the System User Scale
timeFrame: 1 measurement during study participation (during 13 weeks)
measure: Measure of feasibility by patients 3: time spent playing the game
timeFrame: during study participation (during 13 weeks)
measure: Measure of feasibility by patients 4: number of dropouts and no shows
timeFrame: during study participation (during 13 weeks)
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Klimmendaal Revalidatiespecialisten
state: Gelderland
Study officials:
References: