eurostimulation for the treatment of mild cognitive impairment in Parkinson*s disease: an acceptability cross-over study

Phase 2

Recruiting

• Conditions: cognitive impairment; thinking problems; 10028037; 10012272

• Registration Number: NL-OMON56853
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Clinical diagnosis of Parkinson*s disease, diagnosed by a neurologist;
- Mild to moderate disease stage (Hoehn & Yahr disease stage < 4);
- Movement Disorders Society Level I criteria for PD-MCI;
- In case of (dopaminergic) medication use, participants are on stable
medication for at least one month before participation and expect to remain on
stable medication during the study.

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 < 14; Scharre et al.,
2010);
- Severe depressive disorder (Beck Depression Inventory - Ib score > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acceptability of the interventions, as measured with an acceptability<br /><br>questionnaire based on the Theoretical Framework of Acceptability (*TFA-PD<br /><br>questionnaire*; Sekhon et al., 2017, 2022). </p><br>