Using magnetic brain stimulation to help thinking and memory after brain tumour treatment
| ISRCTN | ISRCTN16400955 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16400955 |
| Sponsor | University of Liverpool |
| Funders | National Institute for Health and Care Research, Nexstim |
- Submission date
- 02/01/2026
- Registration date
- 19/01/2026
- Last edited
- 19/01/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Many people who are treated for a low-grade glioma (a slow-growing type of brain tumour) experience long-term difficulties with memory, concentration, attention, and thinking skills. These problems can affect everyday life, including work, relationships, and independence, and there are currently very limited treatments available to improve them. The aim of this study is to better understand the type and severity of cognitive (thinking) difficulties experienced by people with low-grade glioma and to find out whether a non-invasive brain stimulation treatment called repetitive transcranial magnetic stimulation (rTMS) can help improve cognitive function.
Who can participate?
Adults aged 18 years or over who were treated surgically for a low-grade glioma at The Walton Centre NHS Foundation Trust from 2013 onwards may be invited to take part. Participation is entirely voluntary, and people can choose which parts of the study they wish to take part in.
What does the study involve?
The study has three parts. In the first part, participants will be asked to complete online questionnaires and computer-based thinking tests at home, which take less than 90 minutes in total and can be completed with breaks. In the second part, researchers will use results from these tests together with existing MRI brain scans to understand how tumour location relates to thinking difficulties. In the third part, a smaller number of participants with cognitive difficulties may be invited to take part in a proof-of-concept study involving several sessions of rTMS over 4 weeks, along with thinking tests and MRI scans over a three-month period.
What are the possible benefits and risks of participating?
Taking part may help participants better understand their own cognitive strengths and difficulties. Some participants who receive rTMS may experience improvements in thinking skills, although this cannot be guaranteed. The risks of taking part are overall low. Online assessments may cause temporary tiredness or frustration. rTMS can cause short-lived side effects such as headache, scalp discomfort, or mild fatigue. Serious side effects, such as seizures, are very rare and safety procedures are in place.
Where is the study run from?
The study is run by the University of Liverpool in collaboration with The Walton Centre NHS Foundation Trust in Liverpool. Some parts of the study are completed entirely online at home, while in-person visits take place at the Walton Centre or nearby research facilities.
When is the study starting and how long will it run for?
The study is planned to start in February 2026 and is expected to run until August 2030.
Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR). Additional support, such as some equipment, is provided by industry partners.
Who is the main contact?
Mr Ahmad Ali, wcft.carelgg-study@nhs.net
Contact information
Public, Scientific, Principal investigator
The Walton Centre NHS Foundation Trust
Lower Lane
Liverpool
L97LJ
United Kingdom
| Phone | +44 (0)151 525 3611 |
|---|---|
| wcft.carelgg-study@nhs.net |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Historical | |
| Assignment | Parallel | |
| Purpose | Device feasibility, Treatment | |
| Scientific title | Cognitive brain rehabilitation using transcranial magnetic stimulation in patients with low grade glioma: a proof-of-concept study | |
| Study acronym | CARE-LGG | |
| Study objectives | 1. Evaluate the long-term cognitive deficits in patients with LGG 2. Identify clinical predictors of cognitive deficits in LGG 3. Establish the utility of remote cognitive testing in patients with brain tumours 4. Generate a spatial map of cognitive deficits in LGG 5. Determine whether rTMS induces any cognitive changes in patients with LGG 6. Determine if any network level changes occur with any cognitive changes induced by rTMS | |
| Ethics approval(s) |
Not yet submitted | |
| Health condition(s) or problem(s) studied | Cognitive deficits in patients previously treated for low grade glioma | |
| Intervention | Only WP3 will be interventional for this study. This will involve 12 sessions of repetitive Transcranial Magnetic Stimulation (rTMS) over 4 weeks. Intermittent Theta Burst dual-target rTMS will be delivered to frontal and parietal targets in the hemisphere contralateral to the treated tumour. The control arm will receive no rTMS. They will only perform the cognitive and MRI assessments to allow comparison. Patients will be allocated to either arm using pairwise randomisation. | |
| Intervention type | Device | |
| Phase | Phase II | |
| Drug / device / biological / vaccine name(s) | Transcranial Magnetic Stimulation | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 31/08/2030 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 52 |
| Key inclusion criteria | WP - Work Package For WP1: 1. Treated for low-grade glioma (grade 2 intrinsic glial tumour) from 2013 onwards at the Walton Centre NHS Foundation Trust 2. Adult patients (>18 years) at time of treatment For WP2: 1. Completed online assessments in WP1 2. Available post-operative volume MRI (T1 or FLAIR) For WP3: 1. Cognitive eligibility: Presence of objective or subjective cognitive deficits defined as >1 SD below the average on any CANTAB test or scoring <55/72 in the Perceived Cognitive Impairments subscale of FACT-Cog 2. Medical stability: no documented change to medical management (chemotherapy, radiotherapy, or surgery) within the last 3 months 3. The invited patients will be selected based on pairwise randomisation from patients who completed assessments in WP1. Pairwise randomisation will be used to balance the two groups on key predictor variables |
| Key exclusion criteria | For WP1: 1. No explicit exclusion criteria For WP2: 1. No explicit exclusion criteria For WP3: 1. Contraindications to strong magnetic fields (applicable to the TMS sessions and the MRI follow-up scans) 2. Active known pregnancy 3. Unable or unwilling to travel to the Sid Watkins building for TMS sessions 4. History of uncontrolled seizures |
| Date of first enrolment | 01/02/2026 |
| Date of final enrolment | 01/12/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Fazakerley
Liverpool
L9 7LJ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
02/01/2026: Study's existence confirmed by the University of Liverpool.
