Trial Outcomes & Findings for Effect of Repetitive Transcranial Magnetic Stimulation on Resting State Brain Activity in Schizophrenia (NCT NCT01620086)
NCT ID: NCT01620086
Last Updated: 2016-10-31
Results Overview
The Auditory Hallucinations Questionnaire (AHQ) will be used to determine the patient's perceptions of change in auditory hallucinations(s). Normal controls do not fill out this measure because they do not have auditory hallucinations. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured. The range of scores is 0-70, higher scores mean more symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"
Results posted on
2016-10-31
Participant Flow
Participant milestones
| Measure |
Controls: Baseline, 1Hz Sham, 1 Hz Active Over Vertex
These subjects are normal controls without schizophrenia who receive baseline testing, then sham rTMS, and then active 1Hz rTMS. All stimulation is for two days and delivered over the control site located at the vertex.
|
Patients: Baseline, Control Site, & 1Hz First
These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz located over the control site at the vertex, and then were randomized to receive 1 Hz over the treatment site in temporal cortex before receiving 10 Hz over the treatment site in temporal cortex. All stimulation is delivered for four days.
|
Patients: Baseline, Control Site, 10Hz First
These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz over the control site at the vertex, and then were randomized to receive 10 Hz over the treatment site in temporal cortex before receiving 1 Hz over the treatment site in temporal cortex. All treatment is for four days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
2
|
|
Overall Study
COMPLETED
|
8
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
0
|
Reasons for withdrawal
| Measure |
Controls: Baseline, 1Hz Sham, 1 Hz Active Over Vertex
These subjects are normal controls without schizophrenia who receive baseline testing, then sham rTMS, and then active 1Hz rTMS. All stimulation is for two days and delivered over the control site located at the vertex.
|
Patients: Baseline, Control Site, & 1Hz First
These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz located over the control site at the vertex, and then were randomized to receive 1 Hz over the treatment site in temporal cortex before receiving 10 Hz over the treatment site in temporal cortex. All stimulation is delivered for four days.
|
Patients: Baseline, Control Site, 10Hz First
These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz over the control site at the vertex, and then were randomized to receive 10 Hz over the treatment site in temporal cortex before receiving 1 Hz over the treatment site in temporal cortex. All treatment is for four days.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
0
|
|
Overall Study
failed study criteria
|
1
|
4
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
Effect of Repetitive Transcranial Magnetic Stimulation on Resting State Brain Activity in Schizophrenia
Baseline characteristics by cohort
| Measure |
Patients
n=6 Participants
Patients with Schizophrenia who meet entry criteria for the study and get stimulation over temporal cortex.
|
Controls
n=8 Participants
These subjects are normal controls without schizophrenia who get stimulation over the vertex.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
29 years
STANDARD_DEVIATION 9.72 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
|
Gender
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Gender
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"Population: Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.
The Auditory Hallucinations Questionnaire (AHQ) will be used to determine the patient's perceptions of change in auditory hallucinations(s). Normal controls do not fill out this measure because they do not have auditory hallucinations. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured. The range of scores is 0-70, higher scores mean more symptoms.
Outcome measures
| Measure |
Controls: 1Hz Control Site Active-Baseline
These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex
|
Controls: Sham Contorl Site rTMS - Baseline
These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex
|
Patients: Control Site-baseline
n=6 Participants
Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz
|
Patients: Active 1Hz Treatment Site - Baseline
n=5 Participants
Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz
|
Patients: Active 10 Hz Treatment Site-baseline
n=6 Participants
Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz
|
|---|---|---|---|---|---|
|
Changes in Auditory Hallucinations Questionnaire (AHQ).
|
—
|
—
|
-2.67 units on a scale
Standard Deviation 2.66
|
-1.80 units on a scale
Standard Deviation 2.86
|
-2.50 units on a scale
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"Population: Three patients had missing data for the control site - baseline condition and the active 1 Hz treatment site -baseline conditions. One patient had missing data for the active 10 Hz treatment site - baseline.
Percent habituation refers to change in the amplitude of the P50 evoked response potential following a 250 ms inter stimulus interval. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.
Outcome measures
| Measure |
Controls: 1Hz Control Site Active-Baseline
n=8 Participants
These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex
|
Controls: Sham Contorl Site rTMS - Baseline
n=8 Participants
These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex
|
Patients: Control Site-baseline
n=3 Participants
Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz
|
Patients: Active 1Hz Treatment Site - Baseline
n=3 Participants
Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz
|
Patients: Active 10 Hz Treatment Site-baseline
n=5 Participants
Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz
|
|---|---|---|---|---|---|
|
Overall Change in the Percent Habituation of the P50 Evoked Response Potential at 250 Inter Stimulus Interval (ISI) Between the Control and Active Treatments (1 and 10 Hz).
|
-17.55 percent of change in wave amplitude
Standard Deviation 39.17
|
-6.52 percent of change in wave amplitude
Standard Deviation 51.65
|
21 percent of change in wave amplitude
Standard Deviation 47.63
|
-23.05 percent of change in wave amplitude
Standard Deviation 89.74
|
-7.65 percent of change in wave amplitude
Standard Deviation 68.3
|
SECONDARY outcome
Timeframe: change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"Population: Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.
HAM-D is a multiple choice questionnaire that clinicians administer to rate the severity of a subject's depression. There are 17 questions; each question has between 3-5 possible responses which increase in severity (range 0 to 52). The clinician chooses the correct response by interviewing the subject and by observing the symptoms. A score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.
Outcome measures
| Measure |
Controls: 1Hz Control Site Active-Baseline
These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex
|
Controls: Sham Contorl Site rTMS - Baseline
These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex
|
Patients: Control Site-baseline
n=6 Participants
Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz
|
Patients: Active 1Hz Treatment Site - Baseline
n=5 Participants
Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz
|
Patients: Active 10 Hz Treatment Site-baseline
n=6 Participants
Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz
|
|---|---|---|---|---|---|
|
Depression Level Changes as Measured by the Hamilton Depression Inventory (HAMD).
|
—
|
—
|
-.083 units on a scale
Standard Deviation 4.02
|
-4.60 units on a scale
Standard Deviation 4.88
|
-3.67 units on a scale
Standard Deviation 6.41
|
Adverse Events
Patients
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Controls
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 |
Patients
n=13 participants at risk
These are schizophrenic patients who meet entry criteria for the study.
|
Controls
n=13 participants at risk
These subjects are normal controls without schizophrenia.
|
|---|---|---|
|
Ear and labyrinth disorders
sinus infection
|
7.7%
1/13 • Number of events 1 • Adverse Events were recorded in a cumulative fashion for patients, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.
|
0.00%
0/13 • Adverse Events were recorded in a cumulative fashion for patients, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.
|
|
Skin and subcutaneous tissue disorders
left tooth pain
|
7.7%
1/13 • Number of events 1 • Adverse Events were recorded in a cumulative fashion for patients, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.
|
0.00%
0/13 • Adverse Events were recorded in a cumulative fashion for patients, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.
|
|
Musculoskeletal and connective tissue disorders
headache
|
23.1%
3/13 • Number of events 3 • Adverse Events were recorded in a cumulative fashion for patients, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.
|
0.00%
0/13 • Adverse Events were recorded in a cumulative fashion for patients, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.
|
Additional Information
Erik Messias, MD
University of Arkansas for Medical Sciences
Phone: 501-526-8142
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place