Motor and Cognitive Symptoms, Progressive Supranuclear Palsy
Conditions
Keywords
Progressive Supranuclear Palsy (PSP), Transcranial direct current stimulation (tDCS)
Brief 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).
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.
Interventions
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.
DEVICESham Condition
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.
Sponsors
University of Salerno
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Randomization, monitoring and data management will be performed locally. Randomization will be performed using an online list randomizer (random.org). The study coordinator will generate the random allocation sequence before enrollment. Then, one sub-investigator will perform clinical evaluations and another one will administer the treatment.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 3-month follow up in verbal fluency task | Baseline (T0); At 3-month (T3) | fluency in verbal names |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 3-month follow up in cognitive symptoms as assessed with Montreal Cognitive Assessment (MOCA) | Baseline (T0); At 3-month (T3) | 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. |
| Change from baseline to 3-month follow up in caregiver distress as assessed with Neuropshychiatric Inventory (NPI) | Baseline (T0); At 3-month (T3) | 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. |
| Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system) | Baseline (T0); At 3-month (T3) | movements recorded with digital sensors (gait and other tasks) |
| Change from baseline to 3-month follow up in attention as assessed with Frontal Assessment Battery (FAB) | Baseline (T0); At 3-month (T3) | 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. |
| Change from baseline to 3-month follow up in caregiver distress as assessed with Zarit Carer Burden Burden Interview (ZBI) | Baseline (T0); At 3-month (T3) | 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. |
| Change from baseline to 3-month follow up in executive function as assessed with Frontal Assessment Battery (FAB) | Baseline (T0); At 3-month (T3) | 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. |
Countries
Italy
Outcome results
None listed