Trial Outcomes & Findings for Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease (NCT NCT05205772)
NCT ID: NCT05205772
Last Updated: 2025-05-21
Results Overview
Degree of change of frontal midline theta (FMT) power on electroencephalography (EEG) after brain stimulation at each site (medial prefrontal cortex, dorsolateral prefrontal cortex, control site).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
At least 30 minutes before initial iTBS, and 30 minutes after each iTBS treatment
Results posted on
2025-05-21
Participant Flow
Participant milestones
| Measure |
Medial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal Cortex
Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
Intermittent theta-burst stimulation (iTBS) is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Medial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control Site
Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control Site
Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Dorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal Cortex
Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Control Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal Cortex
Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Control Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex
Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
|---|---|---|---|---|---|---|
|
Screening
STARTED
|
5
|
4
|
5
|
3
|
7
|
6
|
|
Screening
COMPLETED
|
5
|
4
|
5
|
3
|
7
|
6
|
|
Screening
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Intervention
STARTED
|
5
|
3
|
5
|
3
|
7
|
5
|
|
First Intervention
COMPLETED
|
5
|
2
|
5
|
2
|
6
|
5
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Washout (3 Weeks)
STARTED
|
5
|
2
|
4
|
2
|
6
|
5
|
|
Washout (3 Weeks)
COMPLETED
|
5
|
2
|
4
|
2
|
6
|
5
|
|
Washout (3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
5
|
2
|
4
|
2
|
6
|
5
|
|
Second Intervention
COMPLETED
|
5
|
2
|
4
|
2
|
6
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
5
|
2
|
4
|
2
|
6
|
5
|
|
Third Intervention
COMPLETED
|
5
|
2
|
4
|
2
|
6
|
5
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Medial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal Cortex
n=5 Participants
Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Medial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control Site
n=2 Participants
Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control Site
n=4 Participants
Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Dorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal Cortex
n=2 Participants
Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Control Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal Cortex
n=6 Participants
Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Control Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex
n=5 Participants
Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.
transcranial magnetic stimulation: Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 7.36 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 7.50 • n=2 Participants
|
69.5 years
STANDARD_DEVIATION 3.77 • n=4 Participants
|
74.0 years
STANDARD_DEVIATION 1.00 • n=2 Participants
|
67.0 years
STANDARD_DEVIATION 9.27 • n=6 Participants
|
67.2 years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
67.92 years
STANDARD_DEVIATION 7.78 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
2 participants
n=2 Participants
|
4 participants
n=4 Participants
|
2 participants
n=2 Participants
|
6 participants
n=6 Participants
|
5 participants
n=5 Participants
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At least 30 minutes before initial iTBS, and 30 minutes after each iTBS treatmentPopulation: Data are reported for participants who completed all 3 treatment interventions.
Degree of change of frontal midline theta (FMT) power on electroencephalography (EEG) after brain stimulation at each site (medial prefrontal cortex, dorsolateral prefrontal cortex, control site).
Outcome measures
| Measure |
Medial Prefrontal Cortex Stimulation
n=24 Participants
Participants received transcranial magnetic stimulation to the medial prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Dorsolateral Prefrontal Cortex Stimulation
n=24 Participants
Participants received transcranial magnetic stimulation to the dorsolateral prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Control Site Stimulation
n=24 Participants
Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, Participants received transcranial magnetic stimulation to the control site.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
|---|---|---|---|
|
Change in Frontal Midline Theta EEG Power After Brain Stimulation
|
1.03 microvolts^2/Hz
Standard Deviation 2.41
|
0.44 microvolts^2/Hz
Standard Deviation 2.55
|
1.01 microvolts^2/Hz
Standard Deviation 2.13
|
PRIMARY outcome
Timeframe: At least 30 minutes before initial iTBSDegree of correlation between the Scales for Outcomes in Parkinson's disease - Autonomic (SCOPA-AUT) total score and frontal midline theta EEG power extracted from Baseline pre-stimulation initial visit EEG and SCOPA-AUT questionnaire. The SCOPA-AUT is a validated autonomic symptom survey for people with Parkinson's disease. It contains 6 domains (gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillary, and sexual). The investigators will use the total composite score including all domains. The score range is 0-69, with a total of 23 questions. 0 means no symptoms, 69 is highest burden of symptoms. The FMT and SCOPA-AUT were assessed at baseline. FMT power and SCOPA-AUT were correlated using the Spearman Correlation Coefficient calculation. A positive correlation coefficient indicates a positive relationship between the assessments; higher FMT power correlates with higher symptom burden.
Outcome measures
| Measure |
Medial Prefrontal Cortex Stimulation
n=24 Participants
Participants received transcranial magnetic stimulation to the medial prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Dorsolateral Prefrontal Cortex Stimulation
Participants received transcranial magnetic stimulation to the dorsolateral prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Control Site Stimulation
Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, Participants received transcranial magnetic stimulation to the control site.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
|---|---|---|---|
|
Correlation Between the Scales for Outcomes in Parkinson's Disease - Autonomic (SCOPA-AUT) Total Score and EEG
|
0.255 Spearman Correlation coefficient
|
—
|
—
|
PRIMARY outcome
Timeframe: At least 30 minutes before initial iTBSDegree of correlation between the Orthostatic Hypotension Questionnaire (OHQ) composite score and frontal midline theta EEG power extracted from Baseline pre-stimulation initial visit EEG and OHQ questionnaire. The OHQ consists of two sections: 1-orthostatic hypotension symptom assessment, which includes 6 questions with a score range of 0-66 (0 is no symptoms, 66 is most severe symptoms); and 2-the orthostatic hypotension daily activity scale, which rates interference of symptoms on activities of daily living. This part consists of four questions, and score range is 0-44 (0 is no interference, 44 is most severe interference). The composite OHQ score is the average score between these two subsections. FMT power and OHQ were correlated using the Spearman Correlation Coefficient calculation. A positive correlation coefficient indicates a positive relationship between the assessments; higher FMT power correlates with higher symptom burden.
Outcome measures
| Measure |
Medial Prefrontal Cortex Stimulation
n=24 Participants
Participants received transcranial magnetic stimulation to the medial prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Dorsolateral Prefrontal Cortex Stimulation
Participants received transcranial magnetic stimulation to the dorsolateral prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Control Site Stimulation
Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, Participants received transcranial magnetic stimulation to the control site.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
|---|---|---|---|
|
Correlation Between the Orthostatic Hypotension Questionnaire (OHQ) and EEG
|
0.261 Spearman Correlation coefficient
|
—
|
—
|
PRIMARY outcome
Timeframe: At least 30 minutes before initial iTBSDegree of correlation between degree of orthostatic hypotension and frontal midline theta EEG power will be measured extracted from Baseline pre-stimulation visit EEG and blood pressure measures. Orthostatic vital signs will be measured at least 30 minutes before initial iTBS as follows: blood pressure will be measured after at least 3 minutes of rest in the supine position. Blood pressure will again be measured after 3 minutes of standing. Blood pressure reduction is expressed as the magnitude of reduction, thus a positive number reflects a greater reduction. Lack of blood pressure reduction was coded as '0'. A positive correlation coefficient indicates a positive relationship between the assessments; higher FMT power correlates with higher more severe orthostatic hypotension.
Outcome measures
| Measure |
Medial Prefrontal Cortex Stimulation
n=24 Participants
Participants received transcranial magnetic stimulation to the medial prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Dorsolateral Prefrontal Cortex Stimulation
Participants received transcranial magnetic stimulation to the dorsolateral prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Control Site Stimulation
Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, Participants received transcranial magnetic stimulation to the control site.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
|---|---|---|---|
|
Correlation Between Degree of Orthostatic Hypotension and EEG
|
0.429 Spearman Correlation coefficient
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 minutes pre-iTBS, and 1 day and 4 days after each iTBS treatmentChange in the SCales for Outcomes in Parkinson's disease - Autonomic (SCOPA-AUT) from 30 minutes before stimulation to 1 day after stimulation and 4 days after stimulation. The SCOPA-AUT is a validated autonomic symptom survey for people with Parkinson's disease. It contains 6 domains (gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillary, and sexual). The investigators will use the total composite score including all domains. The score range is 0-69, with a total of 23 questions. 0 means no symptoms, 69 is highest burden of symptoms
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At least 30 minutes pre-iTBS, and day 1 and day 4 after each iTBS treatmentChange in the Orthostatic Hypotension Questionnaire (OHQ) from before to after iTBS. The OHQ will be administered at least 30 minutes before stimulation, and again 1 day and 4 days after stimulation. The OHQ is an orthostatic hypotension symptom survey and consists of two sections. The first is the orthostatic hypotension symptom assessment, which includes 6 questions with a score range of 0-66 (0 is no symptoms, 66 is most severe symptoms). The second part is the orthostatic hypotension daily activity scale, which rates interference of symptoms on activities of daily living. This part consists of four questions, and score range is 0-44 (0 is no interference, 44 is most severe interference). The investigators will calculate the composite OHQ score, which is the average score between these two subsections.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At least 30 minutes before each iTBS treatment, and 30 minutes after each iTBS treatmentChange in the orthostatic blood pressure change from before to after iTBS. Orthostatic vital signs will be measured as follows: blood pressure will be measured after at least 3 minutes of rest in the supine position. Blood pressure will again be measured after 3 minutes of standing. This will be measured at least 30 minutes before brain stimulation, and again 30 minutes after brain stimulation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At least 30 minutes before each iTBS treatment, and day 1 and day 4 after each iTBS treatmentChange in the Beck Depression Inventory II (BDI-II) from before to after iTBS. Participants will complete the BDI-II at least 30 minutes before brain stimulation. The questionnaire will be repeated 1 day and 4 days after stimulation. The BDI-II is a validated depression symptom survey. This survey contains 21 questions, with a score range of 0-63, where 0 means no depression symptoms and 63 indicates severe depression symptoms.
Outcome measures
Outcome data not reported
Adverse Events
Medial Prefrontal Cortex Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dorsolateral Prefrontal Cortex Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Site Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medial Prefrontal Cortex Stimulation
n=25 participants at risk
Participants received transcranial magnetic stimulation to the medial prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Dorsolateral Prefrontal Cortex Stimulation
n=26 participants at risk
Participants received transcranial magnetic stimulation to the dorsolateral prefrontal cortex.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
Control Site Stimulation
n=25 participants at risk
Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, Participants received transcranial magnetic stimulation to the control site.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
0.00%
0/25 • From the time of signing informed consent through 1-3 days following completion of the 3rd intervention, approximately 6-7 weeks total depending upon optional consolidation of screening and Visit 1 as per protocol.
|
3.8%
1/26 • Number of events 1 • From the time of signing informed consent through 1-3 days following completion of the 3rd intervention, approximately 6-7 weeks total depending upon optional consolidation of screening and Visit 1 as per protocol.
|
0.00%
0/25 • From the time of signing informed consent through 1-3 days following completion of the 3rd intervention, approximately 6-7 weeks total depending upon optional consolidation of screening and Visit 1 as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Exacerbation of Muscle Spasms
|
4.0%
1/25 • Number of events 1 • From the time of signing informed consent through 1-3 days following completion of the 3rd intervention, approximately 6-7 weeks total depending upon optional consolidation of screening and Visit 1 as per protocol.
|
0.00%
0/26 • From the time of signing informed consent through 1-3 days following completion of the 3rd intervention, approximately 6-7 weeks total depending upon optional consolidation of screening and Visit 1 as per protocol.
|
0.00%
0/25 • From the time of signing informed consent through 1-3 days following completion of the 3rd intervention, approximately 6-7 weeks total depending upon optional consolidation of screening and Visit 1 as per protocol.
|
Additional Information
Miriam Sklerov, MD, MS
University of North Carolina at Chapel Hill
Phone: 984-974-4401
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place