Parkinson DiseaseNCT06868160
Comparison of Different Non-invasive Electrical Stimulation Protocols to Facilitate Rehabilitation in Parkinson's Disease Subjects With Postural Instability and Gait Disorders
A study testing Rehabilitation, tDCS and tsDCS (first cycle) in people with Parkinson Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The trial will include 51 adult participants with Parkinson's disease and postural instability and gait disorders (PD-PIGD) and 20 age- and sex-matched healthy controls. At baseline (T0) patients will undergo neurological and cognitive/behavioural assessments, gait/balance evaluation, neuroimaging/neurophysiology… Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rehabilitation, tDCS and tsDCS (first cycle)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 45 years \< age ≤ 85 years
- Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria
- Hoehn \& Yahr (H\&Y) score ≤ 4
- PIGD phenotype
- Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks)
- No dementia according to Litvan\'s criteria and Mini-Mental Status Examination score (MMSE) ≥ 24
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- No significant tremor/involuntary movements that could determine artifacts during the MRI acquisition
- Oral and written informed consent to study participation
- Healthy controls' inclusion criteria:
- Sex-matched and age-matched (age range: mean age of PD years ± 15 years)
- Oral and written informed consent to study participation
Who cannot join
- Any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability
- Medical conditions or substance abuse that could interfere with cognition
- Pacemaker or other implanted neurostimulation devices in the head/neck district
- (Other) Contraindications to undergoing MRI examination
- Brain damage at routine MRI, including extensive cerebrovascular disorders
- Denied oral and written informed consent to study participation
- Significant scalp traumatic or surgical wounds or scalp alterations that could determine a risk of infection in the site of non-invasive stimulation or the spread of excessive current from the device (only for patients receiving the neurostimulation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Neurotech Hub
Milan, 20132
Massimo Filippi, Prof., MD, 0226433054 ext. 0039, filippi.massimo@hsr.it
About this study
Official title: Neurotech PD Gait: Multisite Non-invasive Electrical Stimulation to Optimize Motor-cognitive Rehabilitation Response in Parkinson's Disease Subjects With Postural Instability and Gait Disorders
The trial will include 51 adult participants with Parkinson's disease and postural instability and gait disorders (PD-PIGD) and 20 age- and sex-matched healthy controls.
At baseline (T0) patients will undergo neurological and cognitive/behavioural assessments, gait/balance evaluation, neuroimaging/neurophysiology assessments including brain magnetic resonance imaging (MRI), functional Near Infrared Spectroscopy (fNIRS) and Electroencephalography (EEG) acquisitions to assess brain activity, connectivity and structural changes, and blood sample.
Read more
PD-PIGD patients will be randomly allocated in two training groups: the REHAB+SHAM group and the REHAB + STIM group.
The REHAB+SHAM group will perform 2 cycles of dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises (an approach that has been demonstrated to be effective to improve gait and mobility in PD-PIGD), additionally they will undergo SHAM transcranial and trans-spinal stimulation. SHAM stimulation will be performed using the same montage used for transcranial and spinal stimulation (explained below), however an initial current is delivered and programmed to fade off in a brief period of time.
The REHAB + STIM group will perform the same exercises combined with non-invasive stimulation.
Non-invasive stimulation will be administered using tDCS with trans-spinal Direct Current Stimulation (tsDCS) or transcranial Direct Current Stimulation (tDCS) alone combined with SHAMtsDCS.
This design will aid in determining not only whether non-invasive stimulation can enhance rehabilitation outcomes but also whether the combination of tDCS and tsDCS could lead to improved results compared to tDCS alone.
The motor-cognitive training of the REHAB+SHAM group will consist of 2 cycles of SHAM stimulation and training lasting 6 weeks, 3 times per week, about 1 hour each session, separated by a 8-week washout period.
The REHAB + STIM group will undergo 2 cycles of the 6-week training, separated by a 8-week washout period with a cross-over design: half of subjects will first receive 6-week training with tDCS+SHAMtsDCS followed by 6-week tDCS+ tsDCS, while the other half will follow the reverse order, according to a randomization procedure.
After the training (i.e., 6-week visit [W6] and 20-week visit [W20]), PD-PIGD patients will be re-evaluated through neurological, cognitive/behavioural, gait/balance, neuroimaging/neurophysiology assessments and blood sample.
These measures (except for MRI at 14-week [W14] visit) will be also repeated at W14 and 28-week follow-up visits to assess maintenance of results.
20 healthy controls will also be recruited and evaluated at baseline. They will undergo the same assessments administered to PD-PIGD patients at T0 (neurological, cognitive/behavioural assessments, gait/balance evaluation using gait analysis systems, neuroimaging/neurophysiology, blood sample).
- Conditions
- Parkinson Disease
- Being tested
- Rehabilitation, SHAM tDCS, tDCS, tsDCS (first cycle), tsDCS (second cycle)
- Keywords
- Parkinson Disease, Gait, Rehabilitation, Biomarkers, Magnetic Resonance Imaging, Functional Near Infrared Spectroscopy, Non-invasive Electrical Stimulation, Electroencephalogram
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationBehavioural
Two cycles of dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises.
Three 1-hour sessions per week for 6 weeks. Cycle repeated after 8-week washout period.
SHAM tDCSDevice
SHAM stimulation will be performed using the same montage used for transcranial and spinal stimulation, however an initial current is delivered and programmed to fade off in a brief period of time.
tDCSDevice
Anodic tDCS with the anode placed on the of the left DorsoLateral Prefrontal Cortex. Patients will undergo 30 minutes tDCS session preceding rehabilitation
tsDCS (first cycle)Device
Anodic spinal cervical stimulation with anode electrode placed on the spinous process of C3 vertebra and cathode placed on T3. Patients will undergo 30 minutes stimulation session preceding rehabilitation during the first cycle (6 weeks)
tsDCS (second cycle)Device
Anodic spinal cervical stimulation with anode electrode placed on the spinous process of C3 vertebra and cathode placed on T3. Patients will undergo 30 minutes stimulation session preceding rehabilitation during the second cycle (6 weeks after 8-week washout)
SHAM tsDCS (first cycle)Device
SHAM stimulation will have the same montage as tsDCS but run in SHAM more with an initial stimulation at standard intensity, followed by a programmed fade off after a brief time period. Patients will undergo 30 minutes of SHAM stimulation session preceding rehabilitation during the first cycle (6 weeks)
SHAM tsDCS (second cycle)Device
SHAM stimulation will have the same montage as tsDCS but run in SHAM more with an initial stimulation at standard intensity, followed by a programmed fade off after a brief time period. Patients will undergo 30 minutes of SHAM stimulation session preceding rehabilitation during the second cycle (6 weeks after 8-week washout)
SHAM tsDCSDevice
SHAM stimulation will have the same montage as tsDCS but run in SHAM more with an initial stimulation at standard intensity, followed by a programmed fade off after a brief time period. Patients will undergo 30 minutes of SHAM stimulation session preceding rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| REHAB+SHAM | Active comparator | Dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises. Patients will receive SHAM stimulation. Receives: Behavioral: Rehabilitation; Device: SHAM tDCS; Device: SHAM tsDCS |
| REHAB+tDCS+tsDCS | Experimental | Patients will perform the same exercises as REHAB+SHAM group, combined with non-invasive stimulation. Non-invasive stimulation will be administered using tDCS (DorsoLateral Prefrontal Cortex) combined with tsDCS for the first cycle (6 weeks). During the second cycle (6 weeks after 8-week washout) patients will receive tDCS + sham tsDCS. Receives: Behavioral: Rehabilitation; Device: tDCS; Device: tsDCS (first cycle); Device: SHAM tsDCS (second cycle) |
| REHAB+tDCS+SHAMtsDCS | Active comparator | Patients will perform the same exercises as REHAB+SHAM group, combined with non-invasive stimulation. Non-invasive stimulation will be administered using tDCS (DorsoLateral Prefrontal Cortex) combined with SHAM tsDCS for the first cycle (6 weeks). During the second cycle (6 weeks after 8-week washout) patients will receive tDCS + tsDCS. Receives: Behavioral: Rehabilitation; Device: tDCS; Device: tsDCS (second cycle); Device: SHAM tsDCS (first cycle) |
| Healthy subjects | No intervention | Age- and sex-matched healthy subjects recruited to compare gait, neuropsychological, serum, functional magnetic resonance imaging and neurophysiological characteristics at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total execution time of Timed Up and Go test with cognitive dual-task (TUG-COG)
Changes in time taken to complete the timed up and go test with cognitive dual-task: patients are asked to stand up from a chair, walk for three meters, turn and walk back to the chair while counting backwards by 3 starting from 100. Assessment during ON medication phase
Measured: Baseline, week 6, week 14, week 20 and week 28
Secondary outcomes (21)
Total execution time of Timed Up and Go test (TUG)
Changes in time taken to complete the timed up and go test: patients are asked to stand up from a chair, walk for three meters, turn, and walk back to the chair. Assessment during ON medication phase
Measured: Baseline, week 6, week 14, week 20 and week 28
Total execution time of Timed Up and Go test with manual dual-task (TUG-MAN)
Changes in time taken to complete the timed up and go test with manual dual-task: patients are asked to stand up from a chair, walk for three meters, turn, and walk back to the chair while holding a glass full of water. Assessment during ON medication phase
Measured: Baseline, week 6, week 14, week 20 and week 28
Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
MDS-UPDRS evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS contains 65 items divided in four parts (Part I - "non-motor experiences of daily living", Part II - "motor experiences of daily living", Part III - "motor examination", Part IV - "motor complications. Each item is assessed with a 0 to 4 rating system. The total score ranges from 0 to 260 with higher score indicating more severe symptoms. Assessment during ON medication. Only part III assessed also without medication (OFF).
Measured: Baseline, week 6, week 14, week 20 and week 28
Brain functional changes during functional magnetic resonance imaging (MRI) tasks
Changes in functional MRI brain activity assessed during a motor task, a cognitive task and a dual-task. Assessment during OFF medication phase, at least 12 hours after last medication assumption.
Measured: Baseline, week 6, week 20 and week 28
Changes at resting-state functional Near-Infrared Spectroscopy (fNIRS)
Changes in the continuous spectral wave of brain resting activity
Measured: Baseline, week 6, week 14, week 20 and week 28
Changes in Electroencephalography (EEG) signal
Changes in electrical brain activity during resting with eyes open and eyes closed
Measured: Baseline, week 6, week 14, week 20 and week 28
Serum concentration of Neurofilament light chain (NfL)
Serum biomarker of neuroprotection/neurodegeneration
Measured: Baseline, week 6, week 14, week 20 and week 28
Activity Balance Confidence questionnaire (ABC) score
This questionnaire assesses patient-referred balance confidence during 16 daily tasks. Subjects rate their confidence while doing each activity from 0 (no confidence) to 100 (full confidence). Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
10-meter walk test (10MWT) time
Time taken to walk 10 straight meters. Test performed at comfortable and maximal speed. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
Mini Balance Evaluation System Test (MiniBESTest) score
Assessment of different balance systems (anticipatory, reactive postural control, sensory orientation, dynamic gait). MiniBESTest includes 14 items with a score from 0 (severe/unable) to 2 (normal). The maximum score is 28 and a higher score indicates a better balance. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
Five-time sit-to-stand (5STS) time
This test measures the amount of time it takes for a patient to stand up and sit down five times in a row, as quickly as possible with arms folded across their chest. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
Parkinson's Disease Questionnaire (PDQ-39) score
Parkinson's Disease Questionnaire investigates the quality of life of PD patients. It includes 39 questions with 5 possible answers (never, occasionally, sometimes, often, always) and 8 sub-items related to mobility, activities of daily living, emotional well-being, signs of discouragement, social support, cognitions, communication and bodily discomfort. The maximum score is 100 and a low score is an indicator of a good quality of life. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
This questionnaire assesses motor imagery abilities. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) includes 10 items assessing the clarity of the image and the intensity of the sensations that the subject is able to imagine from the first-person perspective (both right and left sides) on a five-point ordinal scale. Total score ranges from 0 to 50 with higher score indicating better motor imagery abilities. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
Vividness of Movement imagery Questionnaire (VMIQ)
This questionnaire measures vividness of imagery in different visual imagery modalities (first and third person view) and kinaesthetic modality.
Patients, for each imagery modality, give a score from 1 (best) to 5 (worse) to the clarity/intensity of 12 imagined actions.
Measured: Baseline, week 6, week 14, week 20 and week 28
Parkinson Fatigue Scale (PFS)
Patient-rated scale that reflects the physical aspects of fatigue in patients with Parkinson's Disease (PD) and measures both the presence of fatigue and its impact on daily function
Measured: Baseline, week 6, week 14, week 20 and week 28
Fatigue Severity Scale (FSS)
9-item scale which measures the severity of fatigue and its effect on a person\'s activities and lifestyle
Measured: Baseline, week 6, week 14, week 20 and week 28
Modified Fatigue Impact Scale (M-FIS)
Provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning
Measured: Baseline, week 6, week 14, week 20 and week 28
New Freezing of Gait Questionnaire (NFoG-Q)
This is a self-reported questionnaire that measures freezing of gait. It consists of 9 items with a total score ranging from 0 (no freezing) to 28. Higher score indicates worse freezing. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
Stride length
Gait parameter obtained using wearable motion sensors. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
Gait velocity
Gait parameter obtained using wearable motion sensors. Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
Cambridge Neuropsychological Test Automated Battery (CANTAB)
This battery of cognitive tests assesses executive functions, memory and visuospatial abilities. Each subtest of the CANTAB battery provides outcome measures in terms of accuracy (right answers, errors and/or missing answers) and reaction times (highest scores are worse) for every condition within the subtest (the different conditions present with different levels of cognitive load). Assessment during ON medication phase.
Measured: Baseline, week 6, week 14, week 20 and week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start8 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Every patient will undergo two rounds of training (6 weeks) with a 8-week washout period in between. Patients will be randomized in two parallel groups: 1/3 of the patients will receive two rounds of rehabilitation + SHAM stimulation; 2/3 of the patients will receive two rounds of rehabilitation + non-invasive STIMULATION. Patients in the STIMULATION group will be further randomized in two groups both receiving tDCS stimulation combined with tsDCS or SHAMtsDCS in a crossover design: one group will receive a first round of rehabilitation + tDCS + tsDCS followed by a round of rehabilitation + tDCS + SHAM tsDCS; the other group will receive the same treatment in an inverted order.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868160
- Sponsor's protocol ID
- NEUROTECH_001 PD gait
- Status last verified
- Nov 2025
- First submitted
- 5 Mar 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotech PD Gait: Multisite Non-invasive Electrical Stimulation to Optimize Motor-cognitive Rehabilitation Response in Parkinson's Disease Subjects With Postural Instability and Gait Disorders
- ClinicalTrials.gov ID
- NCT06868160
- Acronym / sponsor ID
- NEUROTECH_001 PD gait
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Gait, Rehabilitation, Biomarkers, Magnetic Resonance Imaging, Functional Near Infrared Spectroscopy, Non-invasive Electrical Stimulation, Electroencephalogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 10 Mar 2025 (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.
The trial will include 51 adult participants with Parkinson's disease and postural instability and gait disorders (PD-PIGD) and 20 age- and sex-matched healthy controls.
At baseline (T0) patients will undergo neurological and cognitive/behavioural assessments, gait/balance evaluation, neuroimaging/neurophysiology assessments including brain magnetic resonance imaging (MRI), functional Near Infrared Spectroscopy (fNIRS) and Electroencephalography (EEG) acquisitions to assess brain activity, connectivity and structural changes, and blood sample.
PD-PIGD patients will be randomly allocated in two training groups: the REHAB+SHAM group and the REHAB + STIM group.
The REHAB+SHAM group will perform 2 cycles of dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises (an approach that has been demonstrated to be effective to improve gait and mobility in PD-PIGD), additionally they will undergo SHAM transcranial and trans-spinal stimulation. SHAM stimulation will be performed using the same montage used for transcranial and spinal stimulation (explained below), however an initial current is delivered and programmed to fade off in a brief period of time.
The REHAB + STIM group will perform the same exercises combined with non-invasive stimulation.
Non-invasive stimulation will be administered using tDCS with trans-spinal Direct Current Stimulation (tsDCS) or transcranial Direct Current Stimulation (tDCS) alone combined with SHAMtsDCS.
This design will aid in determining not only whether non-invasive stimulation can enhance rehabilitation outcomes but also whether the combination of tDCS and tsDCS could lead to improved results compared to tDCS alone.
The motor-cognitive training of the REHAB+SHAM group will consist of 2 cycles of SHAM stimulation and training lasting 6 weeks, 3 times per week, about 1 hour each session, separated by a 8-week washout period.
The REHAB + STIM group will undergo 2 cycles of the 6-week training, separated by a 8-week washout period with a cross-over design: half of subjects will first receive 6-week training with tDCS+SHAMtsDCS followed by 6-week tDCS+ tsDCS, while the other half will follow the reverse order, according to a randomization procedure.
After the training (i.e., 6-week visit [W6] and 20-week visit [W20]), PD-PIGD patients will be re-evaluated through neurological, cognitive/behavioural, gait/balance, neuroimaging/neurophysiology assessments and blood sample.
These measures (except for MRI at 14-week [W14] visit) will be also repeated at W14 and 28-week follow-up visits to assess maintenance of results.
20 healthy controls will also be recruited and evaluated at baseline. They will undergo the same assessments administered to PD-PIGD patients at T0 (neurological, cognitive/behavioural assessments, gait/balance evaluation using gait analysis systems, neuroimaging/neurophysiology, blood sample).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Every patient will undergo two rounds of training (6 weeks) with a 8-week washout period in between. Patients will be randomized in two parallel groups: 1/3 of the patients will receive two rounds of rehabilitation + SHAM stimulation; 2/3 of the patients will receive two rounds of rehabilitation + non-invasive STIMULATION. Patients in the STIMULATION group will be further randomized in two groups both receiving tDCS stimulation combined with tsDCS or SHAMtsDCS in a crossover design: one group will receive a first round of rehabilitation + tDCS + tsDCS followed by a round of rehabilitation + tDCS + SHAM tsDCS; the other group will receive the same treatment in an inverted order.
| Arm | Type | Receives |
|---|---|---|
| REHAB+SHAM | Active comparator | Behavioral: Rehabilitation, Device: SHAM tDCS, Device: SHAM tsDCSDual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises. Patients will receive SHAM stimulation. |
| REHAB+tDCS+tsDCS | Experimental | Behavioral: Rehabilitation, Device: tDCS, Device: tsDCS (first cycle), Device: SHAM tsDCS (second cycle)Patients will perform the same exercises as REHAB+SHAM group, combined with non-invasive stimulation. Non-invasive stimulation will be administered using tDCS (DorsoLateral Prefrontal Cortex) combined with tsDCS for the first cycle (6 weeks). During the second cycle (6 weeks after 8-week washout) patients will receive tDCS + sham tsDCS. |
| REHAB+tDCS+SHAMtsDCS | Active comparator | Behavioral: Rehabilitation, Device: tDCS, Device: tsDCS (second cycle), Device: SHAM tsDCS (first cycle)Patients will perform the same exercises as REHAB+SHAM group, combined with non-invasive stimulation. Non-invasive stimulation will be administered using tDCS (DorsoLateral Prefrontal Cortex) combined with SHAM tsDCS for the first cycle (6 weeks). During the second cycle (6 weeks after 8-week washout) patients will receive tDCS + tsDCS. |
| Healthy subjects | No intervention | –Age- and sex-matched healthy subjects recruited to compare gait, neuropsychological, serum, functional magnetic resonance imaging and neurophysiological characteristics at baseline |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 45 years \< age ≤ 85 years
- Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria
- Hoehn \& Yahr (H\&Y) score ≤ 4
- PIGD phenotype
- Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks)
Key exclusion criteria (7 listed)
- Any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability
- Medical conditions or substance abuse that could interfere with cognition
- Pacemaker or other implanted neurostimulation devices in the head/neck district
- (Other) Contraindications to undergoing MRI examination
- Brain damage at routine MRI, including extensive cerebrovascular disorders
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 |
|---|---|---|
| RehabilitationTwo cycles of dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises. Three 1-hour sessions per week for 6 weeks. Cycle repeated after 8-week washout period. | Behavioural | REHAB+SHAM, REHAB+tDCS+SHAMtsDCS, REHAB+tDCS+tsDCS |
| SHAM tDCSSHAM stimulation will be performed using the same montage used for transcranial and spinal stimulation, however an initial current is delivered and programmed to fade off in a brief period of time. | Device | REHAB+SHAM |
| tDCSAnodic tDCS with the anode placed on the of the left DorsoLateral Prefrontal Cortex. Patients will undergo 30 minutes tDCS session preceding rehabilitation | Device | REHAB+tDCS+SHAMtsDCS, REHAB+tDCS+tsDCS |
| tsDCS (first cycle)Anodic spinal cervical stimulation with anode electrode placed on the spinous process of C3 vertebra and cathode placed on T3. Patients will undergo 30 minutes stimulation session preceding rehabilitation during the first cycle (6 weeks) | Device | REHAB+tDCS+tsDCS |
| tsDCS (second cycle)Anodic spinal cervical stimulation with anode electrode placed on the spinous process of C3 vertebra and cathode placed on T3. Patients will undergo 30 minutes stimulation session preceding rehabilitation during the second cycle (6 weeks after 8-week washout) | Device | REHAB+tDCS+SHAMtsDCS |
| SHAM tsDCS (first cycle)SHAM stimulation will have the same montage as tsDCS but run in SHAM more with an initial stimulation at standard intensity, followed by a programmed fade off after a brief time period. Patients will undergo 30 minutes of SHAM stimulation session preceding rehabilitation during the first cycle (6 weeks) | Device | REHAB+tDCS+SHAMtsDCS |
| SHAM tsDCS (second cycle)SHAM stimulation will have the same montage as tsDCS but run in SHAM more with an initial stimulation at standard intensity, followed by a programmed fade off after a brief time period. Patients will undergo 30 minutes of SHAM stimulation session preceding rehabilitation during the second cycle (6 weeks after 8-week washout) | Device | REHAB+tDCS+tsDCS |
| SHAM tsDCSSHAM stimulation will have the same montage as tsDCS but run in SHAM more with an initial stimulation at standard intensity, followed by a programmed fade off after a brief time period. Patients will undergo 30 minutes of SHAM stimulation session preceding rehabilitation | Device | REHAB+SHAM |
Primary outcome
Total execution time of Timed Up and Go test with cognitive dual-task (TUG-COG)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Changes in time taken to complete the timed up and go test with cognitive dual-task: patients are asked to stand up from a chair, walk for three meters, turn and walk back to the chair while counting backwards by 3 starting from 100. Assessment during ON medication phase
21 secondary outcomes
Total execution time of Timed Up and Go test (TUG)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Total execution time of Timed Up and Go test with manual dual-task (TUG-MAN)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
Time frame: Baseline, week 6, week 14, week 20 and week 28
Brain functional changes during functional magnetic resonance imaging (MRI) tasks
Time frame: Baseline, week 6, week 20 and week 28
Changes at resting-state functional Near-Infrared Spectroscopy (fNIRS)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Changes in Electroencephalography (EEG) signal
Time frame: Baseline, week 6, week 14, week 20 and week 28
Serum concentration of Neurofilament light chain (NfL)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Activity Balance Confidence questionnaire (ABC) score
Time frame: Baseline, week 6, week 14, week 20 and week 28
10-meter walk test (10MWT) time
Time frame: Baseline, week 6, week 14, week 20 and week 28
Mini Balance Evaluation System Test (MiniBESTest) score
Time frame: Baseline, week 6, week 14, week 20 and week 28
Five-time sit-to-stand (5STS) time
Time frame: Baseline, week 6, week 14, week 20 and week 28
Parkinson's Disease Questionnaire (PDQ-39) score
Time frame: Baseline, week 6, week 14, week 20 and week 28
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Vividness of Movement imagery Questionnaire (VMIQ)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Parkinson Fatigue Scale (PFS)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Fatigue Severity Scale (FSS)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Modified Fatigue Impact Scale (M-FIS)
Time frame: Baseline, week 6, week 14, week 20 and week 28
New Freezing of Gait Questionnaire (NFoG-Q)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Stride length
Time frame: Baseline, week 6, week 14, week 20 and week 28
Gait velocity
Time frame: Baseline, week 6, week 14, week 20 and week 28
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline, week 6, week 14, week 20 and week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation, tDCS and tsDCS (first cycle) in people with Parkinson Disease, run by IRCCS San Raffaele 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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federica Agosta, PhD, MD (0226433051 ext. 0039, agosta.federica@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total execution time of Timed Up and Go test with cognitive dual-task (TUG-COG) (time frame: Baseline, week 6, week 14, week 20 and week 28). 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 3 Dec 2025.