6 / Brief resume of intended work:
6.1 Need for the study:
Parkinson’s disease (PD) is a chronic progressive disease of the nervous system characterized by the cardinal features of rigidity, bradykinesia, tremor and postural instability.1
The non-motor symptoms of PD have been described since they were first reported by James Parkinson.2 However they have been largely neglected by both physicians and patients compared to the typical motor symptoms, which are the main symptoms corresponding to the criteria for the diagnosis.3
In fact, PD patients report many non-motor symptoms such as cognitive dysfunction, psychiatric disturbances, sleep disorders, dysautonomia, and sensory symptoms.4 The disease may cause disorders of speech, voice and swallowing.1
Patients with PD also experience drooling. It is estimated to occur in 75% of all the patients at some point during the evolution of disease.5 17% -77% of patients with drooling have social and emotional consequences.6 It is particularly problematic while sleeping or in initiating speech and in advance cases increases risk of aspiration.7, 8
The factors that may cause or increase drooling in PD were found. It was estimated that more pooling of saliva occurs in mouth due to decrease in frequency of swallowing and antecollis,6 tongue bradykinesia,9 stooped posture,10 and as a side effect of anti-psychotic agents and cholinesterase inhibitors which are given to control hallucinations in PD patients.11 Hyper salivation is unlikely to induce drooling.12-14
A study reported, presence of hallucinations (based on UPDRS I) was there in PD droolers. Drooling is the side effect of anti- psychotic agents and cholinesterase inhibitor to control hallucinations. The study couldn’t find out if the large number patients defined as droolers had some cognitive deficits. The researchers suggest a possibility that neuropsychological testing could reveal small cognitive deficits in droolers that may not be apparent from day to day interaction thus, identifying drooling as an early sign of decreasing cognitive skills in PD patients.11
In PD, impairments in cognitive function and dementia have been highlighted as particularly common non-motor complications. The estimated prevalence of cognitive impairment in cross-sectional investigations of Parkinson’s disease Dementia (PDD) ranges from 20% - 44% constituting an approximate 3- to 6- fold increased risk of PD patients as compared to non PD patients.15
Cognitive function is degraded in “off”state of medication.16
Studies have shown that there are four dilemmas of rehabilitation for people with cognitive deficits.
Firstly, individual may not be able to accomplish demands of motor performance as they cannot easily understand the instruction of the therapist.17-18
Secondly, they may not concentrate on motor learning because of attention problems.19-21
Third, may not use cognitive function to direct motor learning because cognitive function is separated from motor process.20
Finally, repetition of motor performance task may be impaired because these individuals may not remember what has been done. Therefore, people with cognitive impairments cannot actively participate in a physical training procedure.21
In the literature, there has been no study done wherein the relation between the cognitive deficit and drooling is been found. If drooling is the early sign of declining cognitive skills then early rehabilitation may prevent the further cognitive decline.
Thus, the aim of the present study is to find out the relation of drooling with cognitive deficits using Drooling Severity and Frequency Scale (DSFS) and Mini Mental State Examination (MMSE), respectively in Parkinson’s disease.
Hypothesis:
Null hypothesis
Drooling is not related to cognition in Parkinson’s disease patients.
Alternate hypothesis
Drooling is related to cognition in Parkinson’s disease patients.
6.2 Review of Literature:
Tombaugh TN,McIntyre NJ. (1993) aimed to provide psychometric properties and utility of Mini Mental State Examination (MMSE). They found that reliability and construct validity of the scale were satisfactory. The MMSE provides a brief screening test that quantitatively assesses the severity of cognitive impairment and documents cognitive changes occurring over time.23
Ana Caline no´ Bregaa, Bernardo Rodriguesa, Ana CatarinaTorresa, Renata D’arc Scarpelb, Carolina Alves Nevesb, Ailton Meloa (2007). The aim of their study was todetermine if drooling is associated with dysphagia in PD patients. Sixteen PD patients with diurnal drooling were assessed using modified barium swallowing with videofluoroscopy, and a drooling score. They showed a correlation between the drooling scale score and the level of dysphagia (-0.426; p<0.05). Patients with the worst dysphagia had the worst drooling.22
Johanna G.Kalf, Anne M.Smit, Bastiaan R.Bloem, Machiel J. Zwarts, Martin Munneke (2007) investigated the severity and consequences in PD. They found that the drooling is the considerable problem in PD. 73% of the subjects had scored mild to moderate drooling, but as severe and incapacitating by 27% of patients. Drooling was reported most frequent when patients are relaxing (75%-100%) or tired (75%-94%) or during concurrent activities like walking (70%-88%) and significantly more among severe drooling patients (p=0.00). Drooling during eating was reported less frequent (57%-65%). The social and emotional consequences range from 41%-88% which are significantly higher in severely than in mildly drooling patients.15
Oliver Reidel, Jens Klotsche, et al (2008) studied the frequency of Dementia and Cognitive impairment in patients fulfilling the UK Brain Bank Criteria for Idiopathic PD. Cognitive impairment was assessed by Mini Mental State Examination (MMSE), Clock Drawing Test (CDT), and Dementia by Parkinson’s Neuropsychometric Dementia Assessment (PANDA) and based on diagnostic criteria of DSM IV. Using standardized cut-off scores they found out that all estimates increased with age and PD severity. Gender was an inconsistent contributor and disease duration had no significant impact on cognition.16
Joshua Leibner, Amit Rajit, Laura Sedig, et al. (2009) studied 58 PD droolers and 51 age matched controls. 41% of controls and 59% of patients were droolers (<0.01) as per drooling severity score. The outcome measure was drooling severity and quality of life (PDQ-39). PD droolers had worst quality of life and had more difficulty speaking, eating and socially interacting compared to PD non droolers. Experiencing hallucinations was the only factor that correlated with being a drooler which may be confounded by medication.14
Laura Zamarian, Elisabeth M. Weiss and Margaret Delazer (2010) compared the performance of Mild Cognitive Impairment (MCI) patient in Iowa Gambling Task (IGT) and in the Probability Associated Gambling Task–Revised (PAG-R), with performance of healthy aging peers. MCI patients experienced difficulties in learning from feedback in IGT and in PAG-R, the patients had problems in integrating information from different sources and in adapting there strategy to changes in the decision situation.8
6.3 Objective of the study:
To find out relationship of drooling with cognition in Parkinson’s disease patient.
7 / Materials and Methods:
7.1 Source of Data
1. Employee State Insurance Hospital. Rajajinagar, Bangalore.
2. K.C. General Hospital, Malleshwaram, Bangalore.
7.2Method of collection of data:
Source of data:
Population: Subjects diagnosed with Parkinson’s disease.
Sample design: Convenience sampling.
Sample size: 30 subjects.
Study design: Correlation Study.
Duration of study: 6 months
Inclusion criteria:
•Subjects of both genders.
•Subjects of age group 60 – 80 yr.
•Subjects with Modified Hoehn and Yahr stage more than or equal to 2.
Exclusion criteria:
•Presence of any other neurological disease other than PD.
•Subjects with auditory/visual impairment.
•Subjects with stooping posture (UPDRS III)
•Subjects on anti psychotic drugs.
Materials used:
  • Unified Parkinson’s Disease Rating Scale (motor subscale)
Methodology:
Subjects diagnosed by neuro-physician as having Parkinson’s disease and who fulfill inclusion and exclusion criteria will be included in the study. Informed consent will be taken from the subjects. Detailed neurological examination will be performed on the subjects. Participants will be explained about the procedure and will be assessed using the following scales. Two scales are used in the study:
  • MMSE
MMSE is indicated in
  1. Cognitive function assessment and
  2. Documentation of cognitive function decline
The total score is out of 30 points wherein it checks Orientation (10 points),
Registration (3 points) and Recall (3 points), Attention and Calculation (5 points) and Language (9 points).
The interpretation of MMSE (max. 30 points)
Normal = 24 points or higher
Mild = 21-25 points
Moderate =16-21 points
Severe =below 21
  • DSFS
Drooling severity and frequency scale is a semi-quantitative assessment of the amount of drooling which is used in PD patients.
There are 2 questions:
Severity is rated on a 5 point scale(never drools; mild drooling; moderate drooling; severe drooling; profuse drooling), whereas
Frequency is rated on a 4 point scale (no drooling to constant drooling).
The DSFS scores and MMSE scores will be compared.
Measuring tools:
  • MMSE for assessment of cognitive function.
  • Drooling Severity and Frequency Scale (DSFS) for assessment of drooling.
  • Statistical analysis:
  • Statistical analysis will be performed by using SPSS software for Windows (version 17).
  • Spearman’s Correlation Rho test will be done to find out relationship of drooling with cognition.
7.4 Ethical Clearance:
As this study involve human subjects the Ethical Clearance has been obtained from the Ethical committee of Padmashree Institute of Physiotherapy, Nagarbhavi, Bangalore as per the ethical guidelines for Bio-medical research on human subjects, 2000 ICMR, New Delhi.
8 /

List of References:

1.Susan B O’Sullivan, Thomas J Schmitz. Physical rehabilitation. 5th ed. New Delhi: Jaypee Brothers Medical Publishers; 2007. p. 853.

  1. Parkinson. J. an essay on the shaking palsy. London: Sherwood Neely and Jones;1817.
  2. Shulman LM, Taback RL, Rabinstein AA, Weiner WJ. Non-recognition of depression and other motor symptoms in PD. Parkinson’s Related Disorder 2002;8:193-7.
  3. Chaudhuri KR, Yates L, Martinez- Martin P. The no-motor symptom complex of Parkinson’s Disease – a comprehensive assessment is essential. Curr Neurol Neurosci Rep 2005;5:275-83.
  4. Bagheri H, Damase – Michel C, Lapeyre – Mestre M, Cismondo S, O’COnell D, Senard JM, Rascol O, Montastruc JL(1999). A study of Salivary secretion in Parkinson’s disease. Clin neuropharmacol 22;213-215.
  5. Bateson MC, Gibberd FB, Wilson RSE (1973). Salivary symptoms in PD. Arch of Neurol 29:274-275
  6. Mayeux R : Behavioral and Cognitive Dysfunction. In Cohen A and Weiner W (eds): The Comprehensive Management of Parkinson’s disease. Demos Medical Publishing. New York 1994. Pg 119.
  7. Laura Zamarian, Elisabeth m. Weiss and Margaret Delazer. The Impact of Mild Cognitive Impairment on Decision Making in Two Gambling Tasks J Gerontol B Psychol Sci Soc Sci(2010)doi:10
  8. Schut LJ. Dementia following Stroke. Clin Geriatr Med. 1988;4:767-784.
  9. Available from siteURL:
  10. Rao N, Jellinek HM, Harberk JK, Fryback DG. The Art of Medicine: subjective measures of predictors of outcome in stroke and traumatic head injury. Arch Phys Med Rehabil 1988;69:179-182.
  11. Proulx M, D Courval FP, Wiseman MA, Panniset M (2005). Salivary production in PD. Mov. Disorder 20: 204-207.
  12. Y. Tsuboi, G. Umemoto, T. Kikut. Neurology, Oral and Maxillofacial Surgery. Parkinsonism and Related Disorders 15S2 (2009) S29-S119.
  13. Joshua Leibner, et al: The impact of and the factors associated with drooling in Parkinson’s disease. Parkinsonism and Related Disorders. Dec 2009.
  14. Kalf JG, Smit AM, Bloem BR, Zwarts MJ, Munneke M. Impact of drooling in Parkinson’s disease. Journal of Nuerology 2007;254:1227-32.
  15. O Reidel, J Klotsche, et al.: Cognitive impairment in 873 patients with Idiopathic Parkinson’s disease. Results from the German Study on Epidemiology of Parkinson’s disease with Dementia (GEPAD). J Neurol (2008) 255: 255-264.
  16. Karatekin C, Mackewicz SW, Seigel MA. A preliminary study of motor problems in children with attention deficit or hyperactivity disorder. Percept Mot skills 2003;97(3pt 2):1267-1280.
  17. Mcdowd JM, Filion DL, pohl PS, et al.: Attentional abilities and functional outcomes following stroke. J Gerontol B Psychol Sci Soc Sci 2003,58;P45-P53.
  18. Dittmor CM, Gliner JA. Bilateral hand performance with divided attention after a cerebral vascular accident. Am J Occup Ther. 1987;41:96-101.
  19. Mulder T. A process –oriented model of human motor behavior: toward a theory – based rehabilitant approach. Phys Ther. 1991;71:157-164.
  20. Zafonte RD, Mann NR, Millis SR et al. Post traumatic amnesia: it’s a relation to functional outcome. Arch Phys Med Rehab:1997:78:1103-06.
  21. Ana caline no´ bregaa, Bernardo Rodriguesa, Ana Catarinatorresa, Renata d’arc scarpelb, Carolina Alves Nevesb, Ailton Meloa. Is drooling secondary to swallowing disorder in Parkinson’s disease? Parkinsonism and Related Disorders 14 (2008) 243–245
  22. Tombaugh TN, McIntyre NJ. The mini-mental state examination: A comprehensive review. J Am Geriatr Soc.1992 Sep;40(9):922-35.