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Investigating the effect of non-invasive transcranial current stimulation on auditory hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in schizophrenia, so selective targeting of this abnormal activity could serve as a treatment for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as auditory hallucinations.
AIM 1: To evaluate the effect of transcranial direct current stimulation (tDCS) (2mA for 20min on five consecutive days) on auditory hallucinations in schizophrenia patients using the change in ratings on the Auditory Hallucination Rating Scale (AHRS) by patients before and after stimulation. We hypothesize that tDCS will modulate the abnormal neuronal activity found in schizophrenic patients and thereby decrease their auditory hallucinations when measured after stimulation.
AIM 2: To evaluate the long term effects of tDCS by having patients give a rating on the AHRS after one month has passed since stimulation and comparing this value to their baseline score and their score immediately after stimulation. We hypothesize that there will remain a significant reduction in auditory hallucination score in participants who received tDCS at one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcranial direct current stimulation (tDCS) | Experimental | 13 subjects total. 2mA stimulation for 20 minutes. |
|
| Sham stimulation | Sham Comparator | 13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device |
| ||
| Sham stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5 | Examining AHRS total score after 5 days of stimulation compared to baseline assessment total. | Baseline, Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of Decrease in AHRS Score Over Time | We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days. | Day 5, One month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavio Frohlich, PhD | University of North Carolina at Chapel Hill, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill, Outpatient STEP Clinic | Chapel Hill | North Carolina | 27599-7250 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22581236 | Background | Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. |
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Subjects randomly assigned to one of two groups, transcranial direct stimulation (tDCS) group or active sham group. tDCS group, direct current was delivered during awake, resting state for 20minutes on 5 consecutive days. Sham stimulation was delivered for an equal period of time and number of sessions. 27 subjects signed consent, 1 withdrew.
Patients recruited through medical providers. Providers knew inclusion/exclusion criteria and discussed the study with patients during their regular appointments. Interested participants contacted the study team. Participants recruited from the STEP clinic (Chapel Hill and Raleigh), and the Burlington ACT team. Recruitment between 4/14 and 9/14.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Direct Current Stimulation (tDCS) | 13 subjects total. 2mA stimulation for 20 minutes. tDCS |
| FG001 | Sham Stimulation | 13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period. Sham stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Based on our randomized block design model, a block size of 10 (subjects, 20 total), 2 levels of (within-factors) TREATMENT and TIME each and a residual standard deviation of 14 (Brunelin et al., 2012), the power of our study is estimated to be 0.85 at the significant level alpha=0.05 and the difference of percentage change in 5 days of 15.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Direct Current Stimulation (tDCS) | 13 subjects total. 2mA stimulation for 20 minutes. tDCS |
| BG001 | Sham Stimulation | 13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period. Sham stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5 | Examining AHRS total score after 5 days of stimulation compared to baseline assessment total. | Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 5 |
|
Adverse event data collected from the beginning of the study (4/2014) through the completion of the study (10/2014) for a total of 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Direct Current Stimulation (tDCS) | 13 subjects total. 2mA stimulation for 20 minutes. tDCS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Flavio Frohlich | UNC Chapel Hill | (919) 966-4584 | flavio_frohlich@med.unc.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D006212 | Hallucinations |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Device |
|
| University of North Carolina, Wake STEP Clinic |
| Raleigh |
| North Carolina |
| 27610 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Auditory Hallucination Rating Scale | Remission according to AHRS: AHRS score equal to 0. AHRS: standardized, clinician-administered rating scale; assesses 11 aspects characteristically associated with auditory hallucination. Individual items are scored on a 5 point (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 44; higher score indicates more severe auditory hallucination symptoms. Scores for each question summed up for total score. | Mean | Standard Deviation | units on a scale |
|
| Positive and Negative Syndrome Scale | Remission according to PANSS: PANSS score equal to 30. PANSS: standardized, clinician-administered rating scale. 3 subscales; Positive Symptom scale: 7 items, Negative Symptom scale: 7 items, General Symptom scale: 16 items. Each item in each subscale are scored on a 7 point (1 to 7) scale, with 1=none/absent and 7=most severe. Total score for Positive Scale: 7 to 49. Total score for Negative Scale: 7 to 49. Total score for general scale: 16 to 112. Total score for PANSS: 30 to 210; higher score indicates more severe symptoms. The PANSS total score by adding the sums of each subscale. | Mean | Standard Deviation | units on a scale |
|
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| Secondary | Persistence of Decrease in AHRS Score Over Time | We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days. | Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up. | Posted | Mean | Standard Deviation | units on a scale | Day 5, One month |
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| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Sham Stimulation | 13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period. Sham stimulation | 0 | 13 | 0 | 13 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |