An interventional study of tDCS, or transcranial direct current stimulation in PSP - Progressive Supranuclear Palsy, sponsored by Nantes University Hospital. Not yet recruiting at 1 site in France. Open to participants aged 40 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease with a prevalence estimated at 6 per 100,000 in France and a rapidly progressive course. In its classic form (known as the Richardson type), it presents with a predominantly axial Parkinsonian syndrome, postural instability with early falls, oculomotor disorders, and cognitive and behavioral disturbances. Apart from levodopa, which may provide a modest improvement in Parkinsonian syndrome in some patients, the current therapeutic approach relies primarily on rehabilitation techniques, with no proven efficacy.
Cognitive-behavioral symptoms are common in this disease and are primarily characterized by impaired executive functions, linked to dysfunction of the frontal cortex. They often have a devastating effect on quality of life, are associated with an increased risk of falls, and represent a considerable burden for caregivers. Among these symptoms, apathy is the most commonly described symptom. Impulsivity, associated with impaired inhibitory control, is present in 32-74% of cases and may coexist with apathy.
Cognitive and behavioral inhibition depends on a complex brain network that includes, among others, the right inferior frontal gyrus (IFG), the dorsolateral prefrontal cortex, the supplementary motor area, the motor cortex, and the basal ganglia. It has recently been shown that patients with PSP have impaired functional connectivity between the right LFC and other brain structures in the network, and that neurotransmitter deficits in the right LFC correlate with their impulsivity Alongside pharmacological approaches, non-invasive brain stimulation techniques are rapidly expanding as a potential therapeutic tool. Transcranial direct current stimulation (tDCS), by modulating cortical excitability, is a promising technique. It is simple to administer and has demonstrated efficacy in several clinical settings.
Furthermore, a recent meta-analysis of 45 clinical studies shows that single or repeated tDCS sessions could modestly but significantly improve the inhibitory response-measured by reaction time in the stop-signal paradigm-especially when active (anodal) stimulation was applied to the right GFI. These studies primarily involved healthy subjects. A few studies have examined the effects of tDCS in neurodegenerative diseases and in PSP. These studies are still preliminary, involving small sample sizes, but are encouraging. Among these, a randomized study comparing tDCS to sham tDCS demonstrated a beneficial effect of a single-session tDCS session targeting the dorsolateral prefrontal cortex on verbal fluency in patients with PSP.
The hypothesis of our study is that applying tDCS stimulation over the right GFI will improve certain cognitive functions and reduce behavioral impulsivity in patients.
Very little data on tDCS in PSP is available to date. Only three studies have been published. With very different designs-including only one randomized trial comparing tDCS to sham tDCS-these studies evaluated the effects of tDCS applied to the dorsolateral prefrontal cortex or to motor and premotor areas on language and motor symptoms, respectively.
In this randomized, double-blind, controlled study, the investigators propose to explore the effects of tDCS on the right GFI on executive functions and, more specifically, on inhibitory control. Another strength of our study is that only patients with proven frontal cerebral hypometabolism on FDG-PET-MRI will be included, which will allow us to test the effect of tDCS on a clearly dysfunctional neural network. Furthermore, as a secondary objective, the investigators will be able to assess whether the effects of tDCS depend on the intensity and/or topography of cerebral hypometabolism.
The neurophysiological effects of a single tDCS session appear to last up to 60 to 90 minutes. In this proof-of-concept study, the assessment tests were deliberately chosen for their short administration time and low test-retest effect. Finally, the Stop Signal Test, already used in this population, is widely used and well-standardized.
This pilot study will provide initial data on the cognitive and motor effects of a tDCS session on the GFI, with a focus on inhibition. Given the limited effectiveness of symptomatic treatments-particularly pharmacological ones-having a new option capable of improving cognitive and/or behavioral performance would have a significant impact on the quality of life of patients and their families. tDCS has the advantage of being easily accessible and generally well-tolerated by patients and could eventually be administered in patients' homes.
If our study demonstrates an improvement in certain cognitive/motor functions, it would lead to a larger-scale study with repeated sessions to assess its benefits over a longer period.
Finally, if an improvement in executive functions is demonstrated in PSP, this could apply to other neurodegenerative diseases.
171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.
This study's planned enrollment of 20 is below the median of 43 across 102 interventional studies indexed under Supranuclear Palsy, Progressive.
Browse Supranuclear Palsy, Progressive studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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18-FDG PET-MRI performed no more than 6 months prior to enrollment and showing:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant will receive active tDCS then sham tDCS during two 20-minute sessions spaced one month apart
Device: tDCS, or transcranial direct current stimulation
Each participant will receive sham tDCS then active tDCS during two 20-minute sessions spaced one month apart
Device: tDCS, or transcranial direct current stimulation
Each participant will receive both active tDCS and sham tDCS during two 20-minute sessions spaced one month apart, with the order of the sessions determined at random.
To evaluate the effect of anodal tDCS targeting the right inferior frontal gyrus (IFG) on a motor-modality cognitive inhibition task, the Stop Signal Task (SST), in patients with PSP.
Stop Signal Reaction Time (SSRT) during the SST (seconds)
Time frame: during the hour before each tDCS session and within 1 hour after each tDCS session
To evaluate, in PSP, the effect of anodal tDCS targeting the right GFI on the components of cognitive inhibition assessed by the SST
Results for each of the two conditions (active / sham) regarding the components of cognitive inhibition in the stop-signal test: reaction time (seconds), number of failed inhibitions, and number of unresponded-to Go stimuli will be combined to obtain a grade (low/high)
Time frame: during the hour before each tDCS session and within 1 hour after each tDCS session
To evaluate, within the PSP, the effect of anodal tDCS targeting the right GFI on scores on the following neuropsychological assessments of verbal cognitive inhibition
Results for each of the two conditions (active / sham) on the Color Word Interference test from the Delis Kaplan Executive System (or Stroop D-KEFS)(scale: Preserved executive functions-Difficulty adapting to novelty)
Time frame: during the hour before each tDCS session and within 1 hour after each tDCS session
To evaluate, within the PSP, the effect of anodal tDCS targeting the right GFI on scores on the following neuropsychological assessments of perseverative motor behavior
Results for each of the two conditions (active / sham) regarding the presence or absence of an applause sign and the presence or absence of palilalia
Time frame: during the hour before each tDCS session and within 1 hour after each tDCS session
To evaluate, within the PSP, the effect of anodal tDCS targeting the right GFI on scores on the following neuropsychological assessments of other executive functions
Results for each of the two conditions (active / sham) on the Phonological and Categorical Verbal Fluency Test-which measures perseverations and clusters-and the Symbol-Digit Modality Test.
Time frame: during the hour before each tDCS session and within 1 hour after each tDCS session
To evaluate, within the PSP, the effect of anodal tDCS targeting the right GFI on scores on the following neuropsychological assessments of social cognition
Results for each of the two conditions (active / sham) on the modified Ekman Emotion Recognition Test (6 emotions).
Time frame: during the hour before each tDCS session and within 1 hour after each tDCS session
To evaluate, within the PSP, the effect of anodal tDCS targeting the right GFI on scores on the following neuropsychological assessments of overall cognitive efficiency
Results for each of the two conditions (active / sham) on the MoCA
Time frame: during the hour before each tDCS session and within 1 hour after each tDCS session
To evaluate, in the PSP, the effect of anodal tDCS targeting the right GFI on motor and bulbar symptoms
Results for each of the two conditions (active / sham) on the PSP-RS scale subscores (ocular motility, bulbar examination, limb examination, gait examination)
Time frame: during the hour before each tDCS session and within 1 hour after each tDCS session
To evaluate the effect of anodal tDCS targeting the right GFI on motor function in PSP
Results for each of the two conditions (active / sham) on the Timed Up and Go Test
Time frame: during the hour before each tDCS session and within 1 hour after each tDCS session
To analyze the effects of tDCS on brain metabolism patterns as assessed by 18-FDG PET-MRI
Effect of tDCS as described in Sections 3 and 4 and the brain binding pattern of the FDG tracer in PET-MRI
Time frame: before and after each tDCS session
To evaluate the clinical effects of tDCS on patients' clinical characteristics
Effect of tDCS as described in Sections 3 and 4, and baseline scores on the PSP-RS scales
Time frame: Baseline, before and after each tDCS session
To evaluate the clinical effects of tDCS on patients' clinical characteristics
Effect of tDCS as described in Sections 3 and 4, and baseline scores on the BREF scales
Time frame: Baseline, before and after each tDCS session
To evaluate the clinical effects of tDCS on patients' clinical characteristics
Effect of tDCS as described in Sections 3 and 4, and baseline scores on the NPI scale
Time frame: Baseline, before and after each tDCS session
Assess participants' perception and acceptance of tDCS stimulation
Number and severity of targeted symptoms (itching, burning, pain, etc.) based on the structured questionnaire developed by Antal et al.40
Time frame: within 1 hour after each tDCS session
Safety Assessment
Number of EI and Defects
Time frame: within 1 hour after each tDCS session
Safety Assessment
Grades of EI and Defects
Time frame: within 1 hour after each tDCS session
Plan to share: Undecided
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Supranuclear Palsy, Progressive →