Drooling in Parkinson’s disease: a case for divided attention

• Register: ISRCTN
• Last refreshed on: 18 June 2018
• Main ID: ISRCTN11045864
• Date of registration: 01/02/2016
• Prospective Registration: No
• Primary sponsor: Northumbria Healthcare NHS Foundation Trust
• Public title: Drooling in Parkinson’s disease: a case for divided attention
• Scientific title: Is drooling in Parkinson’s disease affected by divided attention? A cross-sectional study
• Date of first enrolment: 01/10/2015
• Target sample size: 20
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11045864
• Study type: Observational
• Study design: Cross-sectional study (Other)

Countries of recruitment

United Kingdom

Contacts

• Name: Hannah Reynolds

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients under the care of the Northumbria Parkinson's Disease Services or South Tyneside Speech and Language Therapy Service with a diagnosis of Idiopathic Parkinson's Disease
2. Have a self reported problem with daytime drooling on the Unified Parkinson’s Disease Rating scale subset 2.6 saliva question (Movement Disorder Society 2008)
3. Able to participate in the tasks in the proposed study protocol
4. Giving fully informed consent
Exclusion criteria: 1. Patient unable, for cognitive or physical reasons, to comply with the project protocol
2. Patient has had botulinum toxin therapy or surgery on their saliva glands

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's disease
Nervous System Diseases
Parkinson's disease

Intervention(s)

Baseline condition: 30 minute observation of saliva swallows at rest in a chair. To avoid unintentionally priming the client to monitor their saliva swallows no spoken reference to saliva swallowing will be made. They will be told the baseline phase is to observe them at rest using the microphone and video in preparation for the experiment.

Dual task condition: Design based on Brodsky 2007/12 which used a lexical decision task that had enough cognitive demand to impact on anticipatory stages of swallowing. The task designed for the current study requires participants to decide whether a word they see on screen could be associated or not with a sentence they just heard (e.g. they hear: He picked up the spade. The word they might see could be: garden; card; space). They then have to press a button for yes if related or a button for no if unrelated. The response item will be presented after 250 ms and for 3000 ms or until the person responds. There will be a 250ms interval before the next item is presented. This timing was chosen because it is shown to involve the attentional system in lexical decision making rather than a shorter interval which leads to automatic responses. Items are grouped in 4 blocks and take 30 minutes in total to complete.

Primary Outcome(s)

1. Frequency of saliva swallows, using a swallow detection device. This is a small microphone headset which is worn in the ear and is connected to a small recording device. Software in the recording device allows identification of swallowing sounds, which can then be counted and compared.
2. Observed drooling with and without cognitive load

All subjects will complete a 30 minute baseline assessment for drooling at rest and then then another 30 minute assessment whilst completing a series of cognitive tasks involving reading, listening and decision making.

Secondary Outcome(s)

Self report of drooling, measured using the Unified Parkinson's disease rating scale questionnaire

Secondary ID(s)

Protocol version 5

Source(s) of Monetary Support

Northumbria Healthcare NHS Foundation Trust

Ethics review

Status:
Approval date:
Contact:

Newcastle and North Tyneside 2, 25/09/2015, ref: 15/NE/0257

Results

• Results available: Yes
• Date Completed: 31/08/2016