cognitive impairment thinking problems
Conditions
Interventions
Participants will undergo four consecutive phases: 1) a no-intervention
baseline condition, 2) 12 sessions of 20-minute repetitive transcranial
magnetic stimulation (rTMS) (10Hz) or anodal transcran
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of Parkinson*s disease, diagnosed by a neurologist; - Mild to moderate disease stage (Hoehn & Yahr disease stage
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Indication for dementia based on the SAGE (cut-off 18); - Psychotic disorder (except for benign hallucinations with insight), screened with the Scale for Assessment of Positive Symptoms for Parkinson*s disease; - Indication of alcohol or drug abuse; - Contra-indication for NIBSrTMS according to Magstim Rapid2 Manual; rTMS should not be:: • used on or in the vicinity of patients or users with cardiac demand pacemakers, implanted medication pumps, cochlear devices, implanted defibrillators and/or implanted neurostimulators • used on or in the vicinity of patients with implanted metal objects• used on patients where the skin in the area to be contacted is broken • used on patients who suffer from multiple sclerosis • used on those with large ischaemic scars • used on pregnant women • used on infants under the age of 2 years • used on epileptic individuals • used on those with a family history of convulsions • used on individuals with brain lesions that could affect seizure threshold • used on individuals suffering from multiple sclerosis • used on individuals taking tricyclic antidepressants, neuroleptic agents or any other drug that could lower seizure threshold, • used on individuals suffering from sleep deprivation during rTMS procedures • used on individuals with a heavy consumption of alcohol or those using epileptogenic drugs • used on individuals with severe heart disease or with increased intracranial pressure be used on those who have uncontrolled migraines - Contra-indication for tDCS according to Neuroelectrics Starstim Manual; tDCS should not be used in case of: • Patients with a history of seizures; • Patients with unexplained episodes of loss of consciousness, since such condition could be related with brain alterations or epilepsy; • Patients with unstable or non-controlled neuropsychiatric illness; • Patients having implanted brain medical devices; • Patients with implanted pacemakers; • Patients having any electrically, magnetically or mechanically activated implant; • Patients having cardiac, neural or medication implants; • Patients having vascular clips or any other electrically sensitive support system in the brain; • Patients with serious brain injury; • Patients showing damage of skin at sites of stimulation (the device can only be used in healthy skin without wounds, otherwise the resistance to current can be altered); • Patients suffering from skin problems, such as dermatitis, psoriasis or eczema; • Patients suffering from severe or frequent headaches; • Patients with any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease or active neoplasia; • Pregnant women (women of childbearing age should undertake a pregnancy test to confirm eligibility before treatment). - Contra-indication for MR imaging: • metal in the body (pacemaker, port-a-cath, prosthesis, (cochlear) implant) • previous brain surgery • head trauma that resulted in unconsciousness for at least 1 hour • clips • (old metal containing) tattoo • irremovable piercings • irremovable metal braces • pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability of the interventions, as measured with an acceptability questionnaire based on the Theoretical Framework of Acceptability (*TFA-PD questionnaire*; Sekhon et al., 2017, 2022). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Acceptability and feasibility outcomes supporting the main study parameter, including a) objective feasibility data on intervention compliance and attrition indices of drop-out, b) feasibility of at-home tDCS usage measured with the System Usability Scale (Brooke, 1996), and c) acceptability of the interventions based on qualitative data from focus groups, co-led by the involved end users (*patiëntonderzoekers*) from the Dutch PD Patient Association; 2) Subjective cognitive function (PD-Cognitive Functional Rating Scale; Cognitive Failures Questionnaire); 3) Objective cognitive function (Trail Making Test, Letter Fluency, Tower of London, Rey Auditory Verbal Learning Test (*15 Woordentest*), Symbol Digit Modalities Test, Wechsler Adult Intelligence Scale IV-NL - Digit Span subtest); 4) Neuropsychiatric symptom severity (depression: Beck Depression Inventory-Ib; anxiety: Parkinson Anxiety Scale); 5) Functional mobility (Timed Get-up and Go test); 6) Structural and functional neuroimaging to enhance precision of DLPFC targeting. | — |
Countries
Netherlands
Outcome results
None listed