Parkinson's Disease Nervous System Diseases Parkinson's Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 04/08/2023: 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. _____ Previous 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/08/2023: 1. Grip force accuracy and the time taken to initiate movement will be recorded during each squeeze will be measured continuously using strain gauges mounted in a handgrip dynamometer, interfaced with a data acquisition system 2. Observed-rated symptomology. This will be assessed during the test phase via scores on the MDS-UPDRS (Goetz et al., 2008) Part III Motor Examination. 3. Self-reported symptomology. This will be assessed during the test phase via scores on the MDS-UPDRS (Goetz et al., 2008) Part II Motor Aspects of Experiences of Daily Living (MEDL) questionnaire, on the Parkinson’s Disease Quality of Life Questionnaire (PDQ-8) (Jenkinson et al. 1997). 4. Participant acceptability will be measured via a short interview about the participants’ subjective experience of home-based neurofeedback training _____ Previous secondary outcome measure: Participant acceptability will be measured using a simple short questionnaire asking about the participants’ subjective experience of the procedure at session 6. | — |
Countries
United Kingdom, Wales