NCT07386652: RCT of an ICAP

Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia

Not yet recruiting NA Last updated 13 April 2026

What this trial tests

NA trial testing ICAP in Aphasia Following Cerebral Infarction in 334 participants. Not yet recruiting.

Timeline

1 September 2026

Primary endpoint
31 March 2030

31 August 2030

Quick facts

Lead sponsor	University College, London
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	334
Start date	1 September 2026
Primary completion	31 March 2030
Estimated completion	31 August 2030
Sites	1 location across United Kingdom

Drugs / interventions tested

• ICAP
• Standard Care (in control arm) — full drug profile →

Conditions studied

• Aphasia Following Cerebral Infarction — all drugs for Aphasia Following Cerebral Infarction →

Sponsor

University College, London

Who can join

18 and older, any sex, with Aphasia Following Cerebral Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Research question Does participation in an Intensive Comprehensive Aphasia Programme produce a meaningful change in the communication of people with aphasia, their quality of life and that of their carers?

Background Aphasia is a persistent language disorder that severely impairs communicative abilities. Most commonly induced by a stroke, aphasia reduces quality of life more than any other condition. People with aphasia (PWA) and their carers feel abandoned by the NHS due to the limited treatment options available. Meanwhile, neuroscientific evidence suggests that PWA can make meaningful gains in communicative ability, mood, and quality of life if therapists are given enough time to work with them. Although studies indicate Intensive Comprehensive Aphasia Programmes (ICAPs) are effective ways to deliver such therapy, no randomised controlled trial (RCT) of an ICAP has yet been conducted. the investigators propose conducting the first ever ICAP RCT.

Aims and objectives Clinical: i) To test the efficacy of an ICAP in improving PWAs' language impairment, communicative ability, mood, and quality of life; ii) to measure the quantity and quality of therapy received in the community by the standard care group; iii) to assess the significance of age and time-since-stroke in PWA's responses to ICAP intervention.

Mechanistic: To test whether combining baseline behaviour and MRI brain scans can usefully predict individual patients' responses to the ICAP treatment.

Methods The RCT will test the effect of an ICAP intervention by randomly assigning PWA and their carers to one of two groups receiving either ICAP or standard care at two participating sites. The investigators aim to deliver 100 hours of ICAP therapy over a 4-week schedule to adult PWA who are more than 3 months post-stroke. The investigators will compare the effects of the ICAP, comprising complex interventions with multiple interacting therapeutic components, with standard care, the quantity and quality of which will be recorded by research assistants. The primary outcome measure is a standardized scale for measuring quality of life for PWA (SAQOL-39g). The primary endpoint is 4 months post-randomisation. The investigators will also test for effects at 9 months.

Anticipated impacts The trial could provide the evidence needed to transform how the NHS treats PWA and their carers. If the investigators demonstrate that participating in an ICAP leads to clinically meaningful and sustained improvements, the next stage in achieving wider NHS roll-out will be a multi-centre trial to investigate the cost- and clinical effectiveness of ICAPs across the UK.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.