Transcranial Direct Current Stimulation and Dual Tasks in Parkinson's Disease-tDCS&DT in PD

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The project aims to evaluate the clinical and biological effects on patients with Parkinson's disease of an innovative treatment characterized by the use of transcranial Direct Current Stmulation (tDCs) with Dual Task (DT), i.e. including the performance of motor activities in conjunction with the request of cognitive performance, such as executive functions (creative flexibility, working memory and divided attention). Randomized controlled, double-blind, non-pharmacological study using device.The project involves the enrollment of 30 patients.Participants will be randomized into 2 groups: 15 / group and will carry out activities in DT associated with tDCS real (test group) or sham (control group). Each will carry out 12 rehabilitation sessions (2 / week) of 30 minutes. A follow-up is foreseen for all 12 weeks after the end of the treatment. Patients will undergo, at baseline (T0), at the end of the session (T1) and at 12 weeks (T2), a motor and a cognitive profile, moreover a blood sample will be taken. The project intends to improve the state of Parkinson's patients both thanks to the type of protocol that associates DT and tDCS, and thanks to the verification of the treatment through personalized biological analyzes. In detail, improvement in clinical performance, space-time variables in gait and cognitive tests are expected; the variability of synaptic and pathological markers will serve to verify the effect of the treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• Parkinson's disease patient (Hoehn and Yahr I-III);

• Ability to walk with or without aid for 100 meters,

• Mini Mental State Examination\> 21,

• Ability to express informed consent

Locations
Other Locations
Italy
Dipartimento di scienze neuroriabilitative, Casa di Cura del Policlinico
RECRUITING
Milan
Contact Information
Primary
Paola Antoniotti
antoniottipaola@gmail.com
00393474955464
Backup
Laura Veronelli
l.veronelli@casadicuraigea.it
Time Frame
Start Date: 2022-10-21
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 30
Treatments
Active_comparator: tDCS group
transcranial Direct Current Stimulation group (tDCS group) : patients carry out activities in Dual Task associated with tDCS real.
Sham_comparator: Sham group
Sham group: patients carry out activities in Dual Task associated with tDCS sham.
Related Therapeutic Areas
Sponsors
Leads: Casa di Cura Privata del Policlinico SpA

This content was sourced from clinicaltrials.gov