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Electrical stimulation with rehabilitation to improve walking in Parkinson's disease

Tests electrical stimulation added to walking and balance training in adults with Parkinson's disease.

Key facts

Who runs it
IRCCS San Raffaele
Where
Milan, ItalySee the site
Trial code
Registry title
Comparison of Different Non-invasive Electrical Stimulation Protocols to Facilitate Rehabilitation in Parkinson's Disease Subjects With Postural Instability and Gait Disorders
Status
Recruiting
People taking part
71 people, planned
Started
8 Oct 2025
Expected to end
Jan 2029
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Rehabilitation
  • SHAM tDCS
  • tDCS
  • tsDCS (first cycle)
  • tsDCS (second cycle)
  • SHAM tsDCS (first cycle)
  • SHAM tsDCS (second cycle)
  • SHAM tsDCS
Record updated
3 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Parkinson's disease who have balance and walking problems (PIGD type). It also includes healthy volunteers of similar age and sex as a comparison group.

Age
Over 45 and up to 85 years old.
Sex
All sexes.
Disease stage
Idiopathic Parkinson's disease with the PIGD type (postural instability and gait disorder), Hoehn & Yahr score of 4 or less, no dementia (MMSE score of 24 or more).
Earlier treatment
Stable dopaminergic medication for at least 4 weeks, with no changes during the 28-week observation period.

Main reasons for not taking part

  • Any major systemic, psychiatric, neurological, visual or musculoskeletal disorder, or other cause of walking inability
  • Medical conditions or substance abuse that could interfere with thinking
  • Pacemaker or other implanted neurostimulation device in the head or neck area
  • Contraindications to MRI, or brain damage on routine MRI
  • Significant scalp wounds or scalp changes that could raise infection risk (for those receiving stimulation)

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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
  • 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 take part

  • 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)
  • 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
  • Brain damage at routine MRI, including extensive cerebrovascular disorders
  • Pacemaker or other implanted neurostimulation devices in the head/neck district
  • (Other) Contraindications to undergoing MRI examination
  • Denied oral and written informed consent to study participation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 45 and 85 years old?

Where in Italy

  • San Raffaele Neurotech HubMilan, ItalyContact: Massimo Filippi, Prof., MDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 4 groups in the trial

  • REHAB+SHAMExisting treatment, for comparison

    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.

    Treatment: Rehabilitation, SHAM tDCS, and SHAM tsDCS

  • REHAB+tDCS+tsDCSTreatment being tested

    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.

    Treatment: Rehabilitation, tDCS, tsDCS (first cycle), and SHAM tsDCS (second cycle)

  • REHAB+tDCS+SHAMtsDCSExisting treatment, for comparison

    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.

    Treatment: Rehabilitation, tDCS, tsDCS (second cycle), and SHAM tsDCS (first cycle)

  • Healthy subjectsNo study treatment, for comparison

    Age- and sex-matched healthy subjects recruited to compare gait, neuropsychological, serum, functional magnetic resonance imaging and neurophysiological characteristics at baseline

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Electrical stimulation with rehabilitation to improve walking in Parkinson's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06868160, who can take part
Record updated
3 December 2025