Parkinson Disease
Conditions
Brief summary
The purpose of this study is to investigate the effect of dual-mode non-invasive brain stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in patients with Parkinson's disease (PD) with freezing of gait (FOG).
Detailed description
Patients in the dual-mode group underwent five consecutive daily sessions of dual-mode NIBS with simultaneous high-frequency rTMS and tDCS, whereas patients in the rTMS group underwent high-frequency rTMS with sham tDCS. Assessments of FOG, motor, ambulatory and cognitive function were performed three times: at baseline before NIBS, immediately after NIBS, and one week after cessation of NIBS.
Interventions
DEVICErTMS and tDCS
Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously
DEVICErTMS
Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosed as Parkinson's disease (PD) with freezing of gait * walk independently without walking devices
Exclusion criteria
* pre-existing and active major neurological diseases other than PD * a previous history of seizures * implanted metallic objects that would contraindicate rTMS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Freezing of Gait Questionnaire (FOG-Q) | Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5 | Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dual-mode Group the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously | 16 |
| rTMS Group high-frequency rTMS and sham tDCS
rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Dual-mode Group | rTMS Group | Total |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 7.5 | 63.8 years STANDARD_DEVIATION 8.3 | 63.7 years STANDARD_DEVIATION 7.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 16 Participants | 32 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Korea, Republic of | 16 participants | 16 participants | 32 participants |
| Right Handedness | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Change of Freezing of Gait Questionnaire (FOG-Q)
Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome.
Time frame: Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual-mode Group | Change of Freezing of Gait Questionnaire (FOG-Q) | 12.0 score | Standard Deviation 5 |
| rTMS Group | Change of Freezing of Gait Questionnaire (FOG-Q) | 13.9 score | Standard Deviation 4.9 |