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

Parkinson Disease Clinical Trial

— STIMPARK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05808504
• Other study ID #: C21-76
• Secondary ID: 2022- A00767-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: January 15, 2026

Study information

• Verified date: March 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Paul Sauleau, MD
• Phone: +332 99 28 42 58
• Email: paul.sauleau[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurobehavioral Manifestations
• Parkinson Disease

Intervention

Other:
• Neuropsychological assessment
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
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
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).

Procedure:
• EEG
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)
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.

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in cognitive performance measured by the stop signal reaction time (SSRT) compared between real and sham stimulation conditions		5 months
Secondary	The difference in the dynamic changes in functional networks during the task between real and sham stimulation.	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.	5 months
Secondary	The difference in network parameters derived from graph theory between real and sham stimulation.	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.	5 months
Secondary	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.	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).	5 months