Plain English Summary
Background and study aims
Huntington's disease (HD) is a condition that stops parts of the brain working properly over time. It's passed on (inherited) from a person's parents. It gets gradually worse over time and is usually fatal after a period of up to 20 years. The symptoms usually start at 30 to 50 years of age, but can begin much earlier or later.
Recent advances in brain imaging technology now provide us with the opportunity to not only monitor disease-related changes in HD, but to also develop non-invasive interventions, such as neurofeedback training using real-time functional MRI (rt-fMRI), aiming at helping patients better manage their disease symptoms. Participants learn to regulate their own brain activity in selected regions and networks.
The aim of the current study is two-fold: firstly it is to employ neurofeedback training using real-time fMRI in order to train early stage HD patients and pre-symptomatic gene carriers to regulate their brain activation and manage their disease symptoms. Secondly, it is to assess the effects of neurofeedback training using real-time fMRI in early stage HD patients and pre-symptomatic gene carriers.
Who can participate?
Patients aged 18 years or above, with early stage HD or HD gene carriers without symptoms.
What does the study involve?
Participants will be randomly allocated to receive actual or sham neurofeedback training for controlling symptoms of HD. The participants take part in one baseline visit, four training visits and three post-training follow-up visits. Participation will involve MRI scans at each visit.
What are the possible benefits and risks of participating?
This study involves MRI. This is a painless, non-invasive and safe technique that can obtain detailed images of the brain structure and function. It uses strong magnetic fields to generate the images and, unlike X-ray techniques, there is no ionising radiation. MRI scans are not done on people with certain metal implants (such as pacemakers) and prior to enrolment in the study we will go through a series of questions to ensure that a participant is safe to take part in the study.
Neurofeedback training using MRI is non-invasive and only involves the use of advanced brain imaging equipment to accurately measure and present the participant’s brain activation. Changes in brain plasticity are driven by each person’s internal capacity to improve their behaviour through feedback. No side-effects have ever been reported in the literature and it can be used in combination with other medical treatments. The uniqueness of the proposed approach is that the feedback provided is the brain activity of each person, providing direct access to how the brain responds to disease-related changes and ultimately the ability to regulate this response in order to improve behaviour.
It is important to note that this intervention does not offer a cure for the disease. This is the first time this approach will be used in HD patients, so the degree of symptom improvement, if any, following this method is currently unknown.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
February 2016 to November 2019
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr Marina Papoutsi
05/N046, IRAS 160463
Evaluating the feasibility of real-time fMRI neurofeedback training as a treatment for cognitive symptoms in Huntington's disease
The aim of our project is to develop and test neurofeedback training as a method to induce plasticity in Huntington's disease (HD), with the aim of improving cognitive and motor symptoms.
Approved 05/11/2012, London - Queen Square Research Ethics Committee (Manchester HRA Head Office, 3rd Floor Barlow House
4 Minshull Street, Manchester, M1 3DZ; +44 (0)207 104 8345; NRESCommittee.London-QueenSquare@nhs.net), ref: 05/Q0512/74
Single-centre interventional randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
The study tests real-time fMRI neurofeedback training (NFT).
Participants are randomized into four groups, two treatment groups, one receiving neurofeedback derived from the activity of the Supplementary Motor Area (SMA), and another receiving neurofeedback based on the correlation of SMA and left striatum activity (connectivity NFT), and two sham control groups, matched to each of the treatment groups.
Participants are randomized into the four groups based on the UHDRS total motor score.
The participants take part in one baseline visit, four NFT visits and three post-training follow-up visits. The baseline and follow-up visits include advanced structural and functional MRI scanning up to two months post-training.
Primary outcome measure
Participants’ ability to upregulate NFT target levels without feedback (near transfer) measured using fMRI at baseline and follow up (two months after training)
Secondary outcome measures
Measures of cognitive and psychomotor function at baseline and follow-up (two months after training):
1. Stroop word reading
2. Symbol Digit Modalities Task
3. Emotion Recognition
4. Circle Tracing
5. Paced and Speeded Tapping
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. > 18 years old
2. Pre-symptomatic gene-carriers, i.e. they will carry the HD gene, but will not have been clinically diagnosed (UHDRS diagnostic score of 4 or less) at the time of enrolment, OR
3. Early-stage 1 HD patients, i.e. patients with Total Functional Capacity (TFC) score between 11-13
Target number of participants
32 HD gene-carriers (pre- and manifest)
Participant exclusion criteria
Cannot be scanned in the MRI scanner
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University College London
UCL Huntington's Disease Centre 2nd Floor Russell Square House 10-12 Russell Square
Medical Research Council
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Publication in peer-reviewed journals and presentation in international and national conferences related to neuroscience and Huntington's disease.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
2018 results in https://pubmed.ncbi.nlm.nih.gov/29239063 (added 28/01/2020)