Condition category
Nervous System Diseases
Date applied
27/01/2020
Date assigned
28/01/2020
Last edited
28/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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
m.papoutsi@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marina Papoutsi

ORCID ID

http://orcid.org/0000-0003-0971-8361

Contact details

UCL Huntington's Disease Centre
2nd Floor Russell Square House
10-12 Russell Square
London
WC1B 5EH
United Kingdom
+44 (0)2031087478
m.papoutsi@ucl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

05/N046, IRAS 160463

Study information

Scientific title

Evaluating the feasibility of real-time fMRI neurofeedback training as a treatment for cognitive symptoms in Huntington's disease

Acronym

HD-BrainTrain

Study hypothesis

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.

Ethics approval

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

Study design

Single-centre interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Huntington's disease

Intervention

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.

Intervention type

Other

Phase

Drug names

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

01/02/2014

Overall trial end date

18/11/2019

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32 HD gene-carriers (pre- and manifest)

Participant exclusion criteria

Cannot be scanned in the MRI scanner

Recruitment start date

12/02/2016

Recruitment end date

15/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
UCL Huntington's Disease Centre 2nd Floor Russell Square House 10-12 Russell Square
London
WC1B 5EH
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust

Sponsor details

Suite B
First Floor
Maple House
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 (0)20 3447 5124
randd@uclh.ac.uk

Sponsor type

Research organisation

Website

https://www.uclh.nhs.uk/Pages/home.aspx

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

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

01/02/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 results in https://pubmed.ncbi.nlm.nih.gov/29239063 (added 28/01/2020)

Publication citations

Additional files

Editorial Notes

28/01/2020: Trial’s existence confirmed by the Medical Research Council