Non-invasive brain stimulation for mild cognitive impairment in Parkinson's disease

NEuroStimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease: an Acceptability Cross-over Study

This study is testing two non-invasive brain stimulation methods to see if they can help people with Parkinson's disease who have mild cognitive impairment feel better and improve their thinking skills.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT06399731 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the acceptability of two non-invasive brain stimulation methods, repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), for treating mild cognitive impairment in individuals with Parkinson's disease. Twenty participants will undergo both interventions in a cross-over design, with each phase lasting four weeks, including a no-intervention baseline. The primary focus is on the acceptability of these interventions, while secondary outcomes will assess feasibility, cognitive function, neuropsychiatric symptoms, and motor function. MRI will be utilized to explore personalized targeting of the interventions.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with Parkinson's disease who exhibit mild to moderate cognitive impairment.

Not a fit: Patients with severe depressive disorders or indications of dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new non-pharmacological treatment option for improving cognitive function in patients with Parkinson's disease.

How similar studies have performed: Previous studies have shown promise in using non-invasive brain stimulation techniques for cognitive impairment, but this specific approach is relatively novel.

Eligibility criteria

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 (Litvan et al., 2012):

  * Montreal Cognitive Assessment score range \[21-25\] (Dalrymple-Alford et al., 2010), or
  * performance 1-2 SD below appropriate norms on at least 2 neuropsychological tests, or
  * classification of PD-MCI based on recent (\< 6 months previous to participation) neuropsychological assessment taken elsewhere (report will be requested);- 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:

* 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 rTMS 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 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
  * pregnancy
  * claustrophobia other problems lying still for 45 minutes
  * metal in the teeth
  * neurostimulator (including deep brain stimulation)
* Space-occupying lesion on MRI.

Where this trial is running

Amsterdam, North Holland

• Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)

Study contacts

• Study coordinator: Tim D van Balkom, PhD

Conditions Parkinson Disease; Mild Cognitive Impairment