Communication Bridge™-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia

Abstract

Background Primary progressive aphasia (PPA) is a clinical dementia syndrome. Impairments in language (speaking, reading, writing, and understanding) are the primary and persistent symptoms. These impairments progress insidiously and devastate communication confidence, participation, and quality of life for persons living with PPA. Currently, there are no effective disease modifying treatments for PPA. Speech-language interventions hold promise for mitigating communication challenges and language symptoms. However, evidence regarding their efficacy in PPA is of low quality and there are currently no rigorous randomized trials. Method Communication Bridge™-2 (CB2) is a Stage 2, superiority, single-blind, randomized, parallel group, active-control, behavioral clinical trial delivered virtually within a telehealth service delivery model to individuals with PPA. Ninety carefully characterized participants with clinically confirmed PPA will be randomized to one of two speech-language intervention arms: (1) Communication Bridge™ a dyadic intervention based in communication participation therapy models that incorporates salient training stimuli or (2) the control intervention a non-dyadic intervention based in impairment therapy models addressing word retrieval and language production that incorporates fixed stimuli. The superiority of Communication Bridge™ over the Control arm will be evaluated using primary outcomes of communication confidence and participation. Other outcomes include accuracy for trained words and scripts. Participants complete two therapy blocks over a 12-month period. Outcomes will be measured at baseline, at each therapy block, and at 12 months post enrollment. Discussion The CB2 trial will supply Level 2 evidence regarding the efficacy of the Communication Bridge™ intervention delivered in a telehealth service delivery model for individuals with mild to moderate PPA. An important by-product of the CB2 trial is that these data can be used to evaluate the efficacy of speech-language interventions delivered in both trial arms for persons with PPA. The impact of these data should not be overlooked as they will yield important insights examining why interventions work and for whom, which will advance effectiveness trials for speech-language interventions in PPA. Trial Registration ClinicalTrials.govNCT03371706. Registered prospectively on December 13, 2017.

Perspective of Speech and Language Therapists in Turkey on Primary Progressive Aphasia

“…With the studies conducted in recent years, awareness has been raised about patients with PPA. However, despite the research studies that have been done, the evidence base for non-pharmacological treatment is insufficient (Roberts et al, 2022). There is little literature on the management of speech and language symptoms in people with PPA, and the bulk of these studies were impairment-focused interventions such as word retrieval (Carthery-Goulart et al, 2013).…”

“…Online free therapy resources should be provided, such as the currently implemented “Better Conversations with PPA” (34) package (Volkmer et al, 2018). The “Communication Bridge” intervention, a telehealth service delivery model by Roberts et al, will both provide effective speech-language intervention to people with PPA and evaluate the effectiveness of these interventions (Roberts et al, 2022). The facts that 58.9% ( n : 168) of the SLTs participating in the study had 1 to 2 years of experience post-graduation, and 86.3% ( n : 246) of patients with PPA were referred to SLTs within 1 year of symptom onset show that there has been an awareness in the Turkey in recent years.…”

“…An estimated 60% of PPA cases are associated with some form of frontotemporal lobe degeneration and 40% with the neuropathology of Alzheimer's disease. (Mesulam et al, 2014(Mesulam et al, , 2021aRoberts et al, 2022). Because the ability to communicate with others is devastatingly impaired in people with PPA, specific treatments and therapies addressing speech and language symptoms that can improve quality of life for individuals with PPA and their families/caregivers are of great importance (Roberts et al, 2022).…”

Progress in Primary Progressive Aphasia: A Review

“…In another study, transcranial direct cortical stimulation benefited individuals with nfvPPA and lvPPA (Tsapkini et al, 2018). The "communication bridge" uses telehealth methodologies combined with language training that is tailored to individuals with PPA (Roberts et al, 2022).…”

Suitability of Goal Attainment Scaling in Older Adult Populations with Neurodegenerative Disease Experiencing Cognitive Impairment: A Systematic Review and Meta-Analysis

“…When a patient’s current level of functioning is anchored at “0,” scores above “0” represent functional improvement and scores below “0” represent functional decline. For an example of this approach, see the study by Roberts et al [4]. These approaches are mathematically equivalent [2].…”