Plain English Summary
Background and study aims:
Parkinson’s disease (PD) is a long-term medical condition which is caused by the gradual loss of nerve cells (neurons) in a part of the brain called the substantia nigra. These neurons are normally responsible for producing dopamine, a chemical messenger (neurotransmitter) which carries signals around the brain that help to coordinate movement. In people suffering from PD, these neurons gradually die over time, causing the level of dopamine in the brain to gradually fall. As the levels of dopamine become lower, the brain is unable to coordinate movement as effectively, causing abnormal movements such as stiffness, tremor (uncontrollable shaking) and slowness of movement (bradykinesia). This study is looking at a new method of improving movement in Parkinson’s. EEG-based neurofeedback is a type of training during which people receive real-time information about their brain activity using a visual and auditory representation and learn to control their brain activity. The aim of this study is to look at the impact of neurofeedback training on movement, as well as how receptive PD patients are to this type of therapy.
Who can participate?
Adults with PD who have been on stable treatment for at least one month.
What does the study involve?
Everyone who takes part in the study is visited up to six times by a researcher, either at the University or at home. Participants take part in neurofeedback training. This involves having some sensors attached to their heads to record brain activity, which is displayed on a screen so participants can learn how to control it (e.g. how to increase brain activity and how to make it relax). Participants are asked to make some hand and arm movements and to complete some short questionnaires to find out how different levels of brain activity influence movements. For some of the visits participants are asked not to take their normal Parkinson’s medications on the day of testing to see how brain training method compares to medication management of Parkinson’s symptoms. The sessions take no more than 80-120 minutes in total, and include a discussion with the researcher after the neurofeedback session and as many short breaks as are needed.
What are the possible benefits and risks of participating?
Participants may find it beneficial, interesting and enjoyable to complete the tasks and questionnaires included in the study and to talk with the researcher. There are no notable risks involved with participating.
Where is the study run from?
BCUHB Movement Disorders Clinic, Llandudno General Hospital (UK)
When is study starting and how long is it expected to run for?
March 2015 to March 2018
Who is funding the study?
Betsi Cadwaladr University Health Board (UK)
Who is the main contact?
Dr John Hindle
Dr John Hindle
Department of Care for the Elderly
Betsi Cadwaladr University Health Board
Llandudno General Hospital
ENact-PD version 1
A feasibility trial of alpha frequency neuro-feedback in alleviating motor symptoms in Parkinson’s disease
EEG based neurofeedback will improve motor symptoms in PD over and above the effects of the medication.
The aim of this study is to examine whether EEG neurofeedback can be used to train PD patients to produce “normal” pre-movement alpha ERD and, thus, replicate some of the benefits of L-dopa medication.
1. Ysybyty Gwynedd, Betsi Cadwaladr University Health Board, 13/06/2016, ref: 195863
2. Wales Research Ethics Committee 4 Wrexham, 06/05/2016, ref: 16/WA/0115
Non randomised study
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
The study will employ a fully within-subject design with Session (1, 2, 3, 4, 5, 6) as the repeated-measures factor. This design will allow us to assess: the effects of PD medication on motor function (comparison of session 1 and session 2); the effects of neurofeedback training on motor function (comparison of session 2 and session 6); and a comparison of the relative effects of medication versus neurofeedback training (comparison of effect sizes generated above). The sessions, which will take place on separate days, are described below:
Session 1 (Pre-test “on” medication). To establish baseline (pre-intervention) levels of motor performance, participants will complete a force production task comprising 40 trials. In each trial participants will hold a bespoke handgrip dynamometer and will be asked to produce and maintain as accurately as possible a force equivalent to 10% of their maximum strength for 5 seconds (c.f., Coombes et al., 2009; Wang, Lees & Brown, 1999). A selection of additional tests of motor function commonly adopted in the PD literature will also be assessed including movement latency and velocity (Montgomery et al, 1991), maximum grip force (Benice et al, 2007) and the motor subscale of the MDS-UPDRS (Goetz et al, 2008). Participants will be “on” their prescribed PD medication during the first pre-test session. A self-report measure of symptoms will also be obtained and will ask participants how often they have experienced given symptoms over the previous week. In total there are 37 symptoms which will be asked about. This questionnaire is modified from Hobson et al (1999) quality of life questionnaire in PD.
Session 2 (Pre-test “off” medication). This session will be identical to the pre-test described above but will take place following the overnight withdrawal of PD medication. The pre and post-test sessions (i.e., sessions 1, 2 & 6) will take place in the research laboratories of Bangor University or in patient homes as to the preference of the patient. The subsequent training sessions and the post-test session described below will also take place following overnight withdrawal from medication. All of the training sessions described below will take place in the participant’s own home early in the day to reduce the length of time of being off medication. The research team have experience of such off medication studies at home and have found it to be acceptable to participants.
As a ‘within subject’ comparison study, internal consistency will be ensured with each respective participant tested, consistently, within the same environment, as is their preference (e.g. home or laboratory). This will allow us to observe within subject comparisons and crucially, individual changes pre and post intervention.
Sessions 3, 4 & 5 (Neurofeedback training “off” medication). Neurofeedback training will be implemented using our bespoke Bioexplorer software protocols and a wireless EEG system (PET 4, Brainquiry) for recording EEG at frontal-central regions overlying the motor cortex (plus ocular and muscular artifacts). Participants will receive auditory feedback programmed to be (a) proportional – the pitch of a continuous tone will vary with the level of frontal-central alpha power (b) binary – the tone will change from continuous to silent when a threshold decrease in alpha power value is exceeded, and (c) shaped – the threshold for the continuous-silent transition will become progressively more extreme. Participants will be seated and holding the handgrip dynamometer (same as used in pre-test) with their dominant hand. They will be instructed to try and lower the pitch of the tone from the loudspeaker; when it falls silent they will be cued to squeeze the handgrip dynamometer at a force equivalent to 10% of their maximum for 5 seconds. Participants will undertake 12 × 5 minute bouts of neurofeedback training per session (equating to one hour of exposure to the tone per testing session). The threshold level for the change from continuous to silent will be adjusted every testing session, starting with a sustained 1 second reduction in pre-movement alpha power, and ending with a sustained 3 second reduction in pre-movement alpha power (note: these durations may be modified based on pilot testing). This shaping of feedback increases the likelihood that participants emit the desired pattern of alpha power de-synchronisation.
Session 6 (Post-test “off” medication). Session 6 will be identical to Session 2 described above (i.e., participants perform the grip force task without the neurofeedback tone), thereby allowing us to establish the effectiveness of the neurofeedback intervention.
Primary outcome measures
1. Cortical activity is measured using an EEG at each session (session 1 pre-test “on” medication; session 2 pre-test “off” medication; sessions 3, 4 and 5 neurofeedback training “off” medication, and session 6 post-test “off” medication). The EEG will involve 4 active electrodes (Brainquiry) mounted in a nylon cap and placed at C3, Cz, C4 and Fz sites in accordance with the international 10-20 electrode system
2. Grip force accuracy during each squeeze will be measured continuously using strain gauges mounted in a handgrip dynamometer, interfaced with a data acquisition system (Power 1401) and laptop running Spike2 software at sessions 1, 2 and 6
3. Motor ability will be measured using the newer MDS-UPDRS Parkinson’s motor score and motor quality of life section at sessions 1, 2 and 6
4. Movement onset delay and velocity will be measured using pre- and post-intervention using a simple reaching task at sessions 1, 2 and 6
Secondary outcome measures
Participant acceptability will be measured using a simple short questionnaire asking about the participants’ subjective experience of the procedure at session 6.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Idiopathic PD diagnosed using the UK Brain Bank Diagnostic Criteria
2. Hoehn and Yahr stage 1-3 (Hoehn and Yahr, 1967; Bhidayasiri and Tarsy, 2012)
3. On stable treatment for the last one month and no planned changes over the period of the study
4. Ability to give informed consent
5. Aged 18 years and over
Target number of participants
Participant exclusion criteria
1. Clinical diagnosis of dementia
2. Active psychosis, clinically significant depression or behavioural disturbance
3. Presence of another neurological condition
4. Active adjustment of medication during the predicted study period
5. Inability to give informed consent
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
BCUHB Movement Disorders Clinic
Llandudno General Hospital Hospital Road
Betsi Cadwaladr University Health Board
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned presentation of the results at scientific conferences and publication in scientific journals, as well as preparation of the information for health professionals.
IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting