Transcranial temporal interference stimulation (tTIS) is a non-invasive deep brain stimulation method. This study aims to comprehensively explore the efficacy and safety of bilateral subthalamic nucleus (STN) tTIS on motor and non-motor symptoms in patients with Parkinson's disease (PD).
This is a single-center, randomized, double-blind, sham-controlled trial for Parkinson's disease (PD). The transcranial temporal interference stimulation (tTIS) intervention period is 5 days, with follow-up assessments conducted immediately after the intervention, 10 days post-intervention, and 30 days post-intervention. The real stimulation group receives bilateral subthalamic nucleus (STN) -targeted tTIS once daily for 5 days. Stimulation parameters: carrier frequencies of 2000/2130 Hz (Δf = 130 Hz), with stimulation lasting 20 minutes on each side. Before the intervention, T1-weighted structural images are acquired for each subject, and computational modeling based on an individual head model is performed to optimize electrode placement, individually focusing on the target side STN region. The sham group follows the same procedure but does not receive effective stimulation. The sham stimulation group receives only 30 seconds of fade-in/fade-out current at the beginning and end of the stimulation period to ensure blinding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
tTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days.
The sham stimulation is administered using the same procedure as the real tTIS.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGChanges of motor function in PD
the scores of UPDRS III \[OFF\])
Time frame: Changes from baseline after 5 days of intervention (Day 5)
Changes of motor function in PD
the scores of UPDRS III \[OFF\] and \[ON\]
Time frame: Day 15, Day 35 (UPDRS III [OFF] ); Day 5, Day 15, Day 35 (UPDRS III [ON])
Changes of Motor Complications in PD
the scores of UPDRS IV
Time frame: Day 5, Day 15, Day 35
Assessment of changes in cognition
the scores of MoCA
Time frame: Day 5, Day 15, Day 35
Assessment of changes in anxiety
the scores of HAMA
Time frame: Day 5, Day 15, Day 35
Assessment of changes in depression
the scores of HAMD
Time frame: Day 5, Day 15, Day 35
Assessment of changes in sleep
the scores of PSQI
Time frame: Day 5, Day 15, Day 35
Assessment of changes in daytime sleepiness
the scores of ESS
Time frame: Day 5, Day 15, Day 35
Assessment of changes in RBD
the scores of RBDSQ
Time frame: Day 5, Day 15, Day 35
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Assessment of changes in RLS
the scores of IRLSRS
Time frame: Day 5, Day 15, Day 35
Assessment of changes in Non-Motor Aspects of Experiences of Daily Living
the scores of UPDRS I
Time frame: Day 5, Day 15, Day 35
Assessment of changes in Motor Aspects of Experiences of Daily Living
the scores of UPDRS II
Time frame: Time Frame: Day 5, Day 15, Day 35