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New treatment option for Parkinson Disease
Official title Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
ClinicalTrials.gov ID: NCT06399731
What this study is testing
- What it's testing
- This cross-over pilot study aims to study the acceptability of two methods of non-invasive brain stimulation for the treatment of Parkinson's disease mild cognitive impairment (PD-MCI) - repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) targeted at the left dorsolateral prefrontal cortex (DLPFC). Twenty participants will undergo both interventions in a cross-over design.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can join
- 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...
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.