Progressive Supranuclear PalsySTIM-PSPNCT04655079
Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP)
A study testing Anodal transcranial direct current stimulation (a-tDCS) in people with Progressive Supranuclear Palsy and Motor and Cognitive Symptoms, run by University of Salerno at 1 site in Italy.
Trial summary
This is a double-blind, randomized, sham-controlled clinical trial that aim to verify the safety and the efficacy of anodal transcranial direct current stimulation (tDCS) on cognitive and motor symptoms in Progressive Supranuclear Palsy (PSP) over the left dorsolateral prefrontal cortex (dlPFC). Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Progressive Supranuclear Palsy, Motor and Cognitive Symptoms
- What is being tested?
- Anodal transcranial direct current stimulation (a-tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 11 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PSP according with Movement Disorder Society (MDS) criteria (Hoglinger et al., 2017);
- Age > 40 and < 89 years;
- Presence of a caregiver supportive the patient for all study procedure;
- Ability to walk for at least 5 steps either independently or with a minimum support (another patients holding patient's arm or with a walker)
Who cannot join
- Presence of electrical stimulators (for example, pacemaker, Deep Brain Stimulation, DBS)
- Difficult in understanding Italian language
- Presence of severe sensory deficits (for example, visual or hearing impairments)
- Education level <5 years
- History of drug abuse
- History of severe psychiatric disorders
Show all 12Show fewer
- History of transient ischemic attacks
- Cortical or sub-cortical vascular lesions
- Seizures or severe heart problems and previous neurosurgical operations
- Absence of subjective cognitive deficits
- MMSE (Mini-Mental State Examination) score <20
- Left-handedness
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro per le Malattie Neurodegenerative (CEMAND) Dipartimento di Medicina e chirurgia, Sezione Neuroscienze, Università di Salerno
Salerno
About this study
Official title: Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) on Motor and Cognitive Symptoms in Progressive Supranuclear Palsy (PSP) (STIM-PSP)
This is a double-blind, randomized, sham-controlled clinical trial that aim to verify the safety and the efficacy of anodal transcranial direct current stimulation (tDCS) on cognitive and motor symptoms in Progressive Supranuclear Palsy (PSP) over the left dorsolateral prefrontal cortex (dlPFC).
Read the detailed description
Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease characterized by deposition of tau and motor, cognitive and behavioral symptoms. Since no effective treatment is available, non-invasive brain stimulation techniques, such as tDCS, could be a valid complementary therapeutic approach. The tDCS modulates the spontaneous activity of the neural network by applying a direct current flow on the cortical brain areas (anodic or cathodic stimulation). Despite its efficacy in psychiatric disorders, the therapeutic use of tDCS in neurodegenerative diseases requires more systematic studies. The aim of this study is to verify the safety and efficacy of tDCS in PSP on motor, cognitive and behavioral symptoms.
- Being tested
- Anodal transcranial direct current stimulation (a-tDCS), Sham Condition
- Keywords
- Progressive Supranuclear Palsy (PSP), Transcranial direct current stimulation (tDCS)
- Medical subject headings
- Supranuclear Palsy, Progressive, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial direct current stimulation (a-tDCS)Device
Also called Active tDCS
tDCS is delivered by a battery-driven constant current stimulator thought a pair of saline soaked surface sponge electrodes. The active electrode (anode) is placed on the scalp over the left dlPFC (F3) according to the 10 to 20 international electroencephalogram coordinates) and the cathode is placed over the right deltoid muscle. During real stimulation a constant current of 2mA (milli Ampere) is applied for 20 minutes.
Sham ConditionDevice
For the sham condition the electrode placement is the same of active tDCS but the electric current is ramped down 5 seconds after the beginning of the stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS group | Experimental | Participants receive anodal tDCS on the left dlPFC for 5 days/week for 2 weeks Receives: Device: Anodal transcranial direct current stimulation (a-tDCS) |
| Sham group | Sham comparator | Participants receive sham stimulation on the left dlPFC for 5 days/week for 2 weeks Receives: Device: Sham Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 3-month follow up in verbal fluency task
fluency in verbal names
Measured: Baseline (T0); At 3-month (T3)
Secondary outcomes (6)
Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system)
movements recorded with digital sensors (gait and other tasks)
Measured: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in cognitive symptoms as assessed with Montreal Cognitive Assessment (MOCA)
Cognitive status assessed with Montreal Cognitive Assessment (MOCA). The cut off is 15,5. The minimum value is 0 and the maximum is 30. Higher scores mean a better outcome.
Measured: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in caregiver distress as assessed with Neuropshychiatric Inventory (NPI)
depression symptoms, apathy, neuropsychiatric symptoms assessed with Neuropshychiatric Inventory (NPI) . The minimum value of distress is 0 and the maximum is 5. Higher scores mean a worse outcome.
Measured: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in executive function as assessed with Frontal Assessment Battery (FAB)
Executive function assessed with Frontal Assessment Battery (FAB). The cut off is 13,4. The minimum value is 0 and the maximum is 18. Higher scores mean a better outcome.
Measured: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in attention as assessed with Frontal Assessment Battery (FAB)
Attention assessed with Frontal Assessment Battery (FAB). The cut off is 13,4. The minimum value is 0 and the maximum is 18. Higher scores mean a better outcome.
Measured: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in caregiver distress as assessed with Zarit Carer Burden Burden Interview (ZBI)
Caregiver distress assessed with Zarit Carer Burden Burden Interview (ZBI). The minimum value is 0 and the maximum is 88. The cut off is 46. Higher scores mean a worse outcome.
Measured: Baseline (T0); At 3-month (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Feb 2021
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be recruited and randomized in two parallel group: group 1 will receive anodal left dlPFC tDCS (real tDCS) and group 2 will receive sham stimulation for 5 days/week for 2 consecutive weeks, in a 2:1 ratio, respectively. Each participant will undergo a clinical evaluation at baseline (T0), immediately after 2 weeks of either real or sham tDCS (T1), at 45-day (T2) and at 3-month follow up (T3) from baseline. PSP phenotypes will be uniformly distributed between treatment arms (ie, =Richardson's syndrome versus non-Richardson's syndrome=1:1).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Picillo, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655079
- Sponsor's protocol ID
- tDCS 01-2020
- Acronym
- STIM-PSP
- Status last verified
- Aug 2023
- First submitted
- 27 Nov 2020
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) on Motor and Cognitive Symptoms in Progressive Supranuclear Palsy (PSP) (STIM-PSP)
- ClinicalTrials.gov ID
- NCT04655079
- Acronym / sponsor ID
- STIM-PSP / tDCS 01-2020
- Keywords
- Progressive Supranuclear Palsy (PSP), Transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomized, sham-controlled clinical trial that aim to verify the safety and the efficacy of anodal transcranial direct current stimulation (tDCS) on cognitive and motor symptoms in Progressive Supranuclear Palsy (PSP) over the left dorsolateral prefrontal cortex (dlPFC).
Detailed description
Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease characterized by deposition of tau and motor, cognitive and behavioral symptoms. Since no effective treatment is available, non-invasive brain stimulation techniques, such as tDCS, could be a valid complementary therapeutic approach. The tDCS modulates the spontaneous activity of the neural network by applying a direct current flow on the cortical brain areas (anodic or cathodic stimulation). Despite its efficacy in psychiatric disorders, the therapeutic use of tDCS in neurodegenerative diseases requires more systematic studies. The aim of this study is to verify the safety and efficacy of tDCS in PSP on motor, cognitive and behavioral symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be recruited and randomized in two parallel group: group 1 will receive anodal left dlPFC tDCS (real tDCS) and group 2 will receive sham stimulation for 5 days/week for 2 consecutive weeks, in a 2:1 ratio, respectively. Each participant will undergo a clinical evaluation at baseline (T0), immediately after 2 weeks of either real or sham tDCS (T1), at 45-day (T2) and at 3-month follow up (T3) from baseline. PSP phenotypes will be uniformly distributed between treatment arms (ie, =Richardson's syndrome versus non-Richardson's syndrome=1:1).
| Arm | Type | Receives |
|---|---|---|
| Real tDCS group | Experimental | Device: Anodal transcranial direct current stimulation (a-tDCS)Participants receive anodal tDCS on the left dlPFC for 5 days/week for 2 weeks |
| Sham group | Sham comparator | Device: Sham ConditionParticipants receive sham stimulation on the left dlPFC for 5 days/week for 2 weeks |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PSP according with Movement Disorder Society (MDS) criteria (Hoglinger et al., 2017);
- Age > 40 and < 89 years;
- Presence of a caregiver supportive the patient for all study procedure;
- Ability to walk for at least 5 steps either independently or with a minimum support (another patients holding patient's arm or with a walker)
Key exclusion criteria (12 listed)
- Presence of electrical stimulators (for example, pacemaker, Deep Brain Stimulation, DBS)
- Difficult in understanding Italian language
- Presence of severe sensory deficits (for example, visual or hearing impairments)
- Education level <5 years
- History of drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal transcranial direct current stimulation (a-tDCS)Also: Active tDCStDCS is delivered by a battery-driven constant current stimulator thought a pair of saline soaked surface sponge electrodes. The active electrode (anode) is placed on the scalp over the left dlPFC (F3) according to the 10 to 20 international electroencephalogram coordinates) and the cathode is placed over the right deltoid muscle. During real stimulation a constant current of 2mA (milli Ampere) is applied for 20 minutes. | Device | Real tDCS group |
| Sham ConditionFor the sham condition the electrode placement is the same of active tDCS but the electric current is ramped down 5 seconds after the beginning of the stimulation. | Device | Sham group |
Primary outcome
Change from baseline to 3-month follow up in verbal fluency task
Time frame: Baseline (T0); At 3-month (T3)
fluency in verbal names
6 secondary outcomes
Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system)
Time frame: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in cognitive symptoms as assessed with Montreal Cognitive Assessment (MOCA)
Time frame: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in caregiver distress as assessed with Neuropshychiatric Inventory (NPI)
Time frame: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in executive function as assessed with Frontal Assessment Battery (FAB)
Time frame: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in attention as assessed with Frontal Assessment Battery (FAB)
Time frame: Baseline (T0); At 3-month (T3)
Change from baseline to 3-month follow up in caregiver distress as assessed with Zarit Carer Burden Burden Interview (ZBI)
Time frame: Baseline (T0); At 3-month (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal transcranial direct current stimulation (a-tDCS) in people with Progressive Supranuclear Palsy and Motor and Cognitive Symptoms, run by University of Salerno at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 3-month follow up in verbal fluency task (time frame: Baseline (T0); At 3-month (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.