NCT04134416

Brain Correlates of Multimodal Rehabilitation in Chronic Post-stroke Aphasia

Completed Phase 3 Last updated 5 November 2020

What this trial tests

Phase 3 trial testing Donepezil in Aphasia in 20 participants. Completed in 20 October 2020.

Timeline

8 January 2019

Primary endpoint
20 October 2020

20 October 2020

Quick facts

Lead sponsor	University of Malaga
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	20
Start date	8 January 2019
Primary completion	20 October 2020
Estimated completion	20 October 2020
Sites	1 location across Spain

Drugs / interventions tested

• Donepezil (DONEPEZIL) — full drug profile →
• Intensive-Language Action Therapy
• Transcranial direct current stimulation

Conditions studied

• Aphasia — all drugs for Aphasia →
• Stroke — all drugs for Stroke →

Sponsor

University of Malaga

Who can join

Adults 18 to 70, any sex, with Aphasia or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Post-stroke aphasia (PSA), the partial or total loss of the ability to produce and/or understand language associated with stroke, is a highly prevalent and disabling disorder that negatively impacts the personal, social and working life of patients and families. Modern theory-based language therapies (LT) with proved efficacy in chronic PSA are brief (weeks), intensive, and oriented to specific domains (e.g., anomia). However, in order to maximize therapeutic benefits, it becomes essential to implement complementary strategies that boost gains in language, communication and behaviour and also to identify predictors of treatment response (demographics, anatomical) that enable to customize interventions adjusting them to each profile (linguistic deficits, brain structure and connectivity). Our group has repeatedly shown that LT combined with cognitive enhancing drugs (CED) (e.g., Donepezil and Memantine) are safe and promote better outcomes that when these interventions are administered separately. Moreover, non-invasive brain stimulation techniques (NIBS), such as transcranial direct current stimulation (tDCS), are also emerging as a promising treatment option for chronic PSA. However, is still unknown whether or not treatments that combine several biological strategies aid to improve outcomes further. Brain changes induced by these interventions and the premorbid characteristic of a "good responder" are also unknown. The aims of this clinical trial are: (1) Study the efficacy of combined treatments in a sample of patients with chronic PSA (n = 40); (2) Document with multimodal neuroimaging the functional and connectivity changes (neuroplasticity) promoted by these interventions; and (3) Identify linguistic, cognitive and behavioural variables that may predict outcomes for each intervention.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Brain-Derived Neurotrophic Factor and Nerve Growth Factor Therapeutics for Brain Injury: The Current Translational Challenges in Preclinical and Clinical Research.
   Sims SK, Wilken-Resman B, Smith CJ, Mitchell A, et al · · 2022 · cited 52× · PMID 35283994 · DOI 10.1155/2022/3889300
2. Spectrum of neuropsychiatric symptoms in chronic post-stroke aphasia.
   Edelkraut L, López-Barroso D, Torres-Prioris MJ, Starkstein SE, et al · · 2022 · cited 12× · PMID 35433325 · DOI 10.5498/wjp.v12.i3.450
3. Better language through chemistry: Augmenting speech-language therapy with pharmacotherapy in the treatment of aphasia.
   Stockbridge MD. · · 2022 · cited 12× · PMID 35078604 · DOI 10.1016/b978-0-12-823384-9.00013-x
4. Reversing the Ruin: Rehabilitation, Recovery, and Restoration After Stroke.
   Stockbridge MD, Bunker LD, Hillis AE. · · 2022 · cited 6× · PMID 36181577 · DOI 10.1007/s11910-022-01231-5
5. Supporting Post-Stroke Language and Cognition with Pharmacotherapy: Tools for Each Phase of Care.
   Stockbridge MD, Keser Z. · · 2023 · cited 3× · PMID 37271792 · DOI 10.1007/s11910-023-01273-3
6. Brain structural and functional correlates of the heterogenous progression of mixed transcortical aphasia.
   López-Barroso D, Paredes-Pacheco J, Torres-Prioris MJ, Dávila G, et al · · 2023 · cited 3× · PMID 37256346 · DOI 10.1007/s00429-023-02655-6
7. No evidence of impediment by three common classes of prescription drugs to post-stroke aphasia recovery in a retrospective longitudinal sample.
   Stockbridge MD, Keser Z, Bunker LD, Hillis AE. · · 2022 · cited 2× · PMID 35749406 · DOI 10.1371/journal.pone.0270135