Authors
»
Blake Lawrence -More
Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2014
INTERVENTION: Participants will be invited to attend the Neurosciences Laboratory at the School of Psychology, Curtin University to complete a pre‐intervention neuropsychological assessment. Upon arrival the researcher will give participants an overview of the present study, clarify doubts and answer questions that participants may have. The researcher will ask participants to carefully read through the information sheet and consent form. Upon receipt of informed consent, participants will be asked to complete 14 different neuropsychological tests assessing cognitive functioning, activities of daily living (ADL), and quality of life (QOL). Thirteen tests are paper/pencil based and one test, Stockings of Cambridge, will be completed on the Cambridge Automated Neuropsychological Test and Assessment Battery (CANTAB). The CANTAB is a touch screen tablet computer comprising a range of established neuropsychological tests. All tests have been appropriately selected and recommended for use in Parkinson's Disease (PD; see Litvan et al., 2012). Prior to each test participants will be given oral instructions outlining how to complete the test. Participants will be offered regular breaks during assessments. If a participant is showing signs of fatigue or distress and they choose to continue, they will be offered additional breaks to assist them in completing the tasks. However, due to possible learning effects participants will be unable to complete a re‐test if they choose to stop an assessment. At completion participants will be thanked for their participation with a $10 gift card. Each participant’s assessment results will be appropriately scored and interpreted and those who meet the inclusion criteria (presence of Mild Cognitive Impairment) will be asked to participate in the next stage of the project. Participants may experience cognitive fatigue during neuropsychological assessments and cognitive training. However, regular breaks will be offered during assessments and Smartbrain Pro creators recommend no more than 45‐minutes of cognitive training to reduce the likelihood of fatigue. The use of tDCS in the present study involves a single 9‐volt battery to apply a constant current (usually one millivolt) for a set period of time (30 minutes). The current is passed through rubber electrodes (6 cm x 4 cm) placed inside sponge conta CONDITION: Mild Cognitive Impairment Parkinson's Disease PRIMARY OUTCOME: Activities of Daily Living ‐ Measure by the Unified Parkinson's Disease Rating Scale (Section 2 ‐ ADL). Cognitive Functioning ‐ Measured by the Mini Mental State Examination, Parkinson's Disease‐Cognitive Rating Scale, Australian National Adult Reading Test (baseline only), Hopkins Verbal Learning Test‐Revised, Judgement of Line Orientation, Boston Naming Test, Rivermead Paragraph Recall Subtest, Letter Number Sequencing, Controlled Oral Word Association, Similarities, Hooper Visual Organisation Test, Stockings of Cambridge, and Stroop Colour‐Word Test. Quality of Life ‐ Measured by the Parkinson's Disease Questionnaire‐39. SECONDARY OUTCOME: Mood ‐ Measured by the Depression, Anxiety, and Stress Scale‐21. INCLUSION CRITERIA: Individuals must meet the following criteria to be eligible to participate in the study: 1) diagnosed with idiopathic Parkinson's Disease by a neurologist or geriatrician in accord with the Unite Kingdom Parkinson's Disease Society Brain Bank Clinical (UKPDSBBC) criteria; 2) describe self‐reported problems with cognition which do not significantly impact on functional independence; 3) presence of mild cognitive impairment in accord with the Movement Disorders Society Level II diagnostic criteria; 4) stable response to antiparkinsonian medication for a minimum period of 2 months. After 90 participants have completed pre‐intervention neuropsychological assessments and met the necessary inclusion criteria and transcranial direct current stimuluation (tDCS) exclusion criteria they will be asked to read an information sheet and sign a consent form for this stage of the project. Then participants will be randomised to one of six intervention groups: (1) standard cognitive training, (2) tailored cognitive training, (3) tDCS, (4) standard cognitive training + tDCS, (5) tailored cognitive training + tDCS, or (6) control. Standard cognitive training involves a set of cognitive tasks administered to participants regardless of their individually different cognitive deficits. Whereas tailored cognitive training is customised to address specific cognitive impairments of the individual (e.g., memory, language, executive functions). Participants allocated to the cognitive training groups will complete three 45‐minute sessions of in‐home computer‐based cognitive training per week for 4‐weeks. Cognitive training will be competed using the Smartbrain Pro program (www.smartbrain.com) and streamed via Optus Mini Wifi modems onto Pendo Pad tablets. During the first week the researcher will visit participants to set up the equipment, teach them how to use the program, answer questions, and ensure they are able to complete the activities. From weeks two to four the researcher will make follow‐up telephone calls to ensure participants are complying with the training and assist them with any issues they may be experiencing. Participants allocated to the groups completing tDCS will complete 4‐sessions of tDCS over 4‐weeks (1‐session per week). tDCS sessions will be delivered by a constant current stimulator (Empi) and involve 30 minutes of constant current 2mA stimulation (equivalent to 0.08 Ma/CM2) over their left dorsal lateral prefrontal cortex, administered with two 35 cm2 sponge electrodes soaked in saline solution. To stimulate the left dorsal lateral prefrontal cortex, the anode electrode will be placed over F3 according to the 10–20 international system for EEG electrodes placement. There will be a period of 30 seconds at the start and end of tDCS for ramp up/ramp down. Participants will relax (read a magazine, have a cup of tea) during each tDCS session. Participants allocated to the cognitive training + tDCS groups will complete the previously described activities simultaneously for 4‐weeks. At completion of the 4‐week cognitive training and tDCS interventions, participants will complete the same neuropsychological tests (as pre‐intervention) at post‐intervention and 3‐month follow‐up.
Epistemonikos ID: e0651020d4a25017f3e14e8ca02604223081b6cb
First added on: Aug 23, 2024