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NCT Number: NCT05808504

Investigation of the Benefits of Electrical Non-invasive Stimulation on Cognitive Symptoms in Parkinson's Disease

Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease.

It is mostly characterized by the presence of motor difficulties. However, it can also be accompanied by cognitive disorders which have an equally significant impact on the quality of life of patients and which are not relieved by any treatment.

Among the functions affected by Parkinson's disease, inhibition is an essential process for adapting our behaviors in daily life. Inhibition allows us to stop an action that is no longer required or appropriate to the situation in which we find ourselves in. For example, it comes into play when we have to stop at a "stop" sign while driving.

Recent studies suggest that it could be possible to improve the functioning of these processes by using non-invasive brain stimulation tools. Transcranial alternating current electrical stimulation has thus showed promising results in improving functions such as working memory. This technique is completely painless and non-invasive and consists in applying an electric current of very low intensity (barely perceptible) at the level of the scalp, using electrodes.

The investigators are conducting a study to test whether transcranial alternating current electrical stimulation could improve the functioning of the inhibition process which is altered in patients. For this, the investigators will measure this process using a task performed on a computer (the Stop Signal Reaction Time Task), as well as brain activity using a method called "electroencephalography", before and after stimulation. For this study, the investigators will include 50 patients and 40 healthy participants to investigate the effect of the stimulation on inhibition.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Inhibition, Psychological Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rennes

Rennes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For all participants:

  • Affiliation to a social security scheme or beneficiary of such a scheme.
  • Age over 18 years old.
  • Age less than 75 years old
  • Correct or correctly corrected view (on simple declaration by the patient).
  • Subject having received information on the protocol and having provided informed and written consent to participate.

Criteria exclusive to patients:

  • Idiopathic Parkinson's disease according to United Kingdom Parkinson's criteria Brain Bank disease (Hughes et al., 1992).

Exclusion criteria

For all participants:

  • Major cognitive impairment (Moca < 22) or severe neurocognitive disorder according to DSM-V (Diagnostic and statistical manual of mental disorders -V);
  • Motor difficulties preventing the achievement of the task.
  • Drug or alcohol addiction.
  • Adult subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
  • Present or past moderate to severe psychiatric pathology (obsessive compulsive, bipolar disorder, schizophrenia, etc.).
  • Potential for pregnancy or confirmed pregnancy. A pregnancy test will be performed on inclusion.for women of childbearing age.

Criteria exclusive to patients:

  • Present or past neurological pathology other than Parkinson's disease (accident stroke, head trauma, etc.).
  • Deep brain stimulation treatment.

Exclusive to healthy participants:

  • Present or past neurological pathology.

Treatment and study plan

Neuropsychological assessment

Other

interview with a neuropsychologist and carrying out tests measuring overall cognitive abilities, depression, apathy and anxiety (respectively using the MOCA, MADRS, LARS, STAI scales)

Neurological assessment

Other

Only for patients with Parkinson disease. Evaluation consisting in a disease severity assessment using the Hoehn and Yahr and Schwab and England scales, as a well as a measure of levodopa equivalent daily dose.

Cognitive task

Other

The task consists in pressing a left or right button as fast and as accurately as possible according to the direction of an arrow displayed at the center of a screen. On 25 % of the trials, a "stop" signal will occur right after the stimulus, indicating the participant to stop his impending button press. The delay between the presentation of the arrow stimulus and the stop signal will be adjusted to ensure a final 50% accuracy (decreased following an accurate response and increased after an error), which is necessary to comply with the assumptions for a robust calculation of the stop signal reaction time (SSRT).

EEG

Procedure

A high-resolution (256 channels) electroencephalographic recording will be done at rest and during the Stop task, before and after each real or sham stimulation.

tACS (real or sham)

Procedure

Real or sham tACS will be applied with the same equipment (StarStim, Neuroelectrics). The stimulation will consist in applying a current (max 2 mA) at frontal sites (F8 and Cz according to standard EEG position, and defined based on dosimetry analyses on averaged head models) for 12-15 minutes during the task. A 10 s ramp (fade-in/fade-out) will be used to avoid current perception of the stimulation and optimize blinding. Sham stimulation will be done using the same protocol, but with no stimulation in between onset and offset.

Primary outcomes

  1. Difference in cognitive performance measured by the stop signal reaction time (SSRT) compared between real and sham stimulation conditions

    Time frame: 5 months

Secondary outcomes

  1. The difference in the dynamic changes in functional networks during the task between real and sham stimulation.

    Time frame: 5 months

    The difference in the dynamic changes in functional networks during the task between real and sham stimulation measured by the averaged lifespan (in ms) if the networks identified with the weighted phase lag index.

  2. The difference in network parameters derived from graph theory between real and sham stimulation.

    Time frame: 5 months

    The difference in network parameters derived from graph theory between real and sham stimulation. measured by the functions of the brain connectivity toolbox (matlab) : degree distribution, path length, betweenness centrality, clustering coefficient.

  3. The existence of correlations between the changes in network measures between real and sham stimulation mentioned above and the behavioral differences measured between real and sham stimulation.

    Time frame: 5 months

    Correlations will be calculated in R using the spearman rank correlations between (i) changes in network measures between real and sham stimulation : averaged network lifespan, degree distribution, path length, betweenness centrality, clustering coefficient, and (ii) behavioral differences in SSRT (ms).

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Acronym: STIMPARK

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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