Condition category
Nervous System Diseases
Date applied
09/05/2017
Date assigned
29/08/2017
Last edited
29/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Dr John Hindle

ORCID ID

http://orcid.org/0000-0001-6979-6607

Contact details

Department of Care for the Elderly
Betsi Cadwaladr University Health Board
Llandudno General Hospital
Llandudno
LL30 1LB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ENact-PD version 1

Study information

Scientific title

A feasibility trial of alpha frequency neuro-feedback in alleviating motor symptoms in Parkinson’s disease

Acronym

ENact-PD

Study hypothesis

Hypothesis:
EEG based neurofeedback will improve motor symptoms in PD over and above the effects of the medication.

Study aim:
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.

Ethics approval

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

Study design

Non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Home

Trial type

Treatment

Patient information sheet

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

Condition

Parkinson's Disease

Intervention

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.

Intervention type

Other

Phase

Drug names

Primary outcome measure

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

01/03/2015

Overall trial end date

31/03/2018

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

n=30

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

01/07/2017

Recruitment end date

01/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

BCUHB Movement Disorders Clinic
Llandudno General Hospital Hospital Road
Llandudno
LL30 1LB
United Kingdom

Sponsor information

Organisation

Betsi Cadwaladr University Health Board

Sponsor details

Research & Development Department
Ysbyty Gwynedd
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Betsi Cadwaladr University Health Board

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

31/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes