Digital Interventions in Neurorehabilitation: iTALKbetter

NCT04566081 | Completed Results DMC

• 1 other identifier: 18\0071
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

iTALKBetter will provide an app-based therapy for people with word retrieval difficulties who have had a stroke. This study aims to test the therapy application for people with naming difficulties through a small scale item-randomized controlled trial.

Conditions

Stroke; Aphasia; Anomia

Keywords

Anomia; Word Retrieval; Digital Therapy

Outcome Measures

Primary Outcomes (1)

• Accuracy Performance (%) on a Bespoke Word Retrieval Test: WRT. Two Conditions: 1. Trained Items 2. Untrained Items

  The WRT is custom test of word retrieval comprised of a subset of the trained and untrained items form the iTALKbetter therapy. Participants accuracy on the word retrieval test is measured at two timepoints: pre intervention (T3), and post intervention (T4). There are 110 trained and 110 untrained items. Accuracy is reported as a percentage score (min = 0%, max = 100%) for each of the four conditions. The outcome is the percentage change in performance on the WRT. To investigate the efficacy of iTalkBetter in improving the retrieval of trained single words on the WRT, a repeated measures ANOVA was used which compared change in accuracy over the pre-therapy block and the therapy block. There were two factors, each with two levels: time (pre-therapy (Baseline to T3) and therapy (T3 to T4)); and item (trained and untrained lexical items).

  Two time points: 1. Pre- intervention (T3 = 6 weeks post baseline) 2. Post-intervention (T4 = 12 weeks post baseline)

Secondary Outcomes (1)

• Qualitative Interviews

  Baseline and Post-intervention (T4 = 12 weeks post Baseline)

Study Arms (1)

iTALKbetter

EXPERIMENTAL

There is only one arm (iTalkBetter), but within this arm there are two conditions, trained and untrained items. These are the therapy items (words). Half are trained and half are untrained. Each participant gets a different mix of trained or untrained items. Participants received iTALKbetter therapy for 6 weeks. Participants are required to use the therapy for 1.5 hours everyday to reach the required dose of 60 hours over the 6 week period.

Behavioral: iTalkBetter Trained Items; Behavioral: iTalkBetter Untrained Items

Interventions

iTalkBetter Trained Items BEHAVIORAL

These are the linguistic items to-be-trained

iTALKbetter

iTalkBetter Untrained Items BEHAVIORAL

These are the psycholinguistically matched untrained items

iTALKbetter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any type of stroke but at least 6 months after onset.
• Evidence of aphasia on the Comprehensive Aphasia Test
• English as their dominant language
• Able to tolerate MRI brain scan
• Able to give informed consent
• Able to use the DNI (app)

You may not qualify if:

• No diagnosis of developmental language disorders
• No diagnosis of severe dementia or primary progressive aphasia
• No major co-existing neurological or psychiatric diagnosis
• No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or other metallic or electronic objects in the body, weight over 24 stone, claustrophobia or pregnancy).

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, WC1E6BT, United Kingdom

Location

Related Publications (1)

• Upton E, Doogan C, Fleming V, Leyton PQ, Barbera D, Zeidman P, Hope T, Latham W, Coley-Fisher H, Price C, Crinion J, Leff A. Efficacy of a gamified digital therapy for speech production in people with chronic aphasia (iTalkBetter): behavioural and imaging outcomes of a phase II item-randomised clinical trial. EClinicalMedicine. 2024 Feb 21;70:102483. doi: 10.1016/j.eclinm.2024.102483. eCollection 2024 Apr.

  PMID: 38685927 DERIVED

MeSH Terms

Conditions

Stroke; Aphasia; Anomia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Alex Leff
• Organization: UCL Queen Square Institute of Neurology

a.leff@ucl.ac.uk

02076791129

Study Officials

• Alexander P Leff, Professor

  University College, London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: September 28, 2020
• Study Start: September 7, 2020
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)