Functional Reorganization and Recovery of the Language and Domain-general Multiple Demand Systems in Aphasia

Browse trials for

• Aphasia 338

Keywords

• Constant Therapy program
• Psychotherapy
• Lifestyle counseling
• Lesion load

Aphasia

338 studies on the registry are indexed under Aphasia; 95 are open to participants now.

This study's planned enrollment of 100 is above the median of 30 across 298 interventional studies indexed under Aphasia.

Lead sponsor

Boston University Charles River Campus is the lead sponsor of 159 studies on the registry; 33 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 9 (64%) have results posted.

Study arms

• Experimental
  Immediate treatment

  Participants randomized to this arm will receive the intervention immediately after baseline behavioral and neural procedures.

  Behavioral: Constant Therapy program

• Active comparator
  Delayed treatment

  Participants randomized to this arm will be put on a waitlist for 5 weeks and will then receive the intervention.

  Behavioral: Constant Therapy program

Interventions

• BehavioralConstant Therapy program

  The Constant Therapy program includes includes 91 therapy exercise programs and participants can practice any of the exercises in the program for 50 hours (60 minutes a day, 5 days a week for 10 weeks).

Primary outcomes

1. Change in the Western Aphasia Battery Revised Aphasia Quotient

   The Western Aphasia Battery Revised Aphasia Quotient (WAB-R-AQ) is a standardized, gold-standard assessment for determining the presence, type, and severity of post-stroke aphasia. The WAB-R measures performance across a variety of expressive and receptive language domains. Weighted performance across four of these domains, namely spontaneous speech, auditory verbal comprehension, repetition, and naming/word finding, yields the WAB-R AQ, a composite score that ranges from 0 to 100, with higher scores indicating better language function.

   Time frame: Baseline, immediately after the 10-week intervention

Secondary outcomes

1. Western Aphasia Battery- Revised Language Quotient (WAB-R LQ)

   The WAB-R measures performance across a variety of expressive and receptive language domains and takes approximately 45-60 minutes to administer. Weighted performance across four of these domains - spontaneous speech, auditory verbal comprehension, repetition, and naming/word finding - yields a composite score, the WAB-R Aphasia Quotient (AQ). The WAB-R AQ is an impairment-based metric that reliably indexes aphasia severity across different aphasia subtypes, making it ideal as a metric for studies with heterogenous patient samples as for the current study. In addition to the AQ, Language Quotients (LQ) can be obtained from a full administration of the WAB-R. LQ is a summary score encompassing both spoken and written language abilities. The LQ is scaled from 0 to 100, where higher numbers reflect stronger overall performance across the tested domains.

   Time frame: Baseline, immediately after the 10-week intervention

2. Western Aphasia Battery- Revised Cortical Quotient (WAB-R CQ)

   The Cortical Quotient (CQ) is a summary score taking into account all subtests of the WAB-R, including not only spoken and written language but also apraxia, constructional, visuospatial and calculation tasks. Administration of tests to calculate CQ and LQ together take approximately 45 minutes. The CQ is scaled from 0 to 100, where higher numbers reflect stronger overall performance across the tested domains.

   Time frame: Baseline, immediately after the 10-week intervention

3. Boston Naming Test (BNT)

   The BNT is one of the most widely used measures of confrontational naming, consisted of 60 line drawings of objects of graded difficulty. It consists of 60 black and white pictures that increase in the order of difficulty (pictures progressively include less frequent words). Scoring comprises accuracy out of 60 items. A point is typically given for items named spontaneously or correctly after a semantic cue (a category or description hint). For healthy, non-brain-damaged adults, average raw scores generally range from 50 to 59 out of 60, depending on age and education level (with normative means clustering around 53 to 55).

   Time frame: Baseline, immediately after the 10-week intervention

4. Pyramids and Palm Trees Test (PPTT)

   The PPTT is a visual semantic association task designed to assess semantic memory and the ability to form and retrieve associations between concepts. For each triad, a target stimulus (e.g., a picture or word of a pyramid) is shown at the top, and two choice options (e.g., a palm tree vs. a fir tree) are shown at the bottom. The subject must point to or select the item that semantically matches the target. There are 52 trials. A score of 47 or higher (90% or better: ≥ 47/52) is generally considered normal, indicating no clinically significant semantic memory deficit. A score below 47 (less than 90%) indicates a clinically significant semantic memory impairment.

   Time frame: Baseline, immediately after the 10-week intervention

5. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

   The RBANS provides a comprehensive assessment of general cognitive skills, including attention, memory, executive function, and visuospatial processing. The battery consists of 12 short subtests divided across five specific cognitive domains: Immediate Memory: List Learning, Story Memory, Visuospatial/Constructional: Figure Copy, Line Orientation, Language: Picture Naming, Semantic Fluency, Attention: Digit Span, Coding, Delayed Memory: List Recall, List Recognition, Story Recall, Figure Recall. Reported total scores range from 40 to 160, with scores 120 or higher as superior performance.

   Time frame: Baseline, immediately after the 10-week intervention

6. Reading Comprehension Battery for Aphasia-2 (RCBA-2)

   The RCBA-2 provides a comprehensive evaluation of the nature and degree of reading impairments at single word-, sentence- and paragraph-level. Lower total scores indicate more severe acquired reading impairments (alexia) associated with aphasia or brain injury. Total score is 0-100 (10 core subtests), typical range is 97.32, whereas aphasic patients tend to score 18-99.

   Time frame: Baseline, immediately after the 10-week intervention

7. Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)

   The SAQOL-39 consists of 39 questions to assess health-related quality of life in individuals with chronic post-stroke aphasia with responses from 1 = Could not do it at all to 5 = No trouble at all. To calculate the scores, the mean (average) value rather than a cumulative sum is calculated and higher means suggest higher quality of life

   Time frame: Baseline, immediately after the 10-week intervention

Individual participant data

Plan to share: No