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The Use of Transcranial Electrical Stimulation for Hallucinations

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ClinicalTrials.gov Identifier: NCT02715765
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
Minneapolis Veterans Affairs Medical Center
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
Schizophrenia is a serious mental health disorder that affects approximately 1% of the population. Auditory hallucinations are present in as many as 50-75% of patients with this diagnosis. The hallucinations experienced by patients vary greatly and can severely impact an individual's ability to function on a daily basis. In approximately 25-30% of these patients, medication is an ineffective mechanism for managing these symptoms. These hallucinations are known as medication refractory auditory hallucination (MRAH). For those whose auditory hallucinations do not respond to medication, non-surgical brain stimulation (NBS) has recently shown promise as a therapeutic intervention. Two specific types of NBS, called transcranial direct current stimulation (tDCS) and transcranial random noise stimulation (tRNS), seem particularly well suited to treating MRAH. They have yet to be compared to each other in large samples of patients with MRAH. The goal of the study is to investigate whether tRNS and tDCS are effective in the treatment of MRAH and if one is better than the other when compared directly.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: Transcranial Direct Current Stimulation Device: Transcranial Random Noise Stimulation Device: Transcranial Sham Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Transcranial Electrical Stimulation for Hallucinations
Study Start Date : July 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Sham Comparator: Sham
The sham procedure involves only 40 sec direct current stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec.
Device: Transcranial Sham Stimulation
Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. The sham procedure involves only 40 sec stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction
Other Name: sham

Experimental: Active tDCS
Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). The current is held constant for 20 min. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.
Device: Transcranial Direct Current Stimulation
Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA. Once at 2mA, the current is held constant for the entire session. At the end of stimulation, current is decreased in a ramp-like fashion over 10s from 2mA to 0mA. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction
Other Name: tdcs

Experimental: Active tRNS
Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). Once at 2mA, an alternating current of 2mA with a 0mA offset is applied at random frequencies over a range of 0.1 to 100 Hz. This is performed for 20 minutes. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.
Device: Transcranial Random Noise Stimulation
Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA. Once at 2mA, the current alternates at 2mA with a 0mA offset applied at random frequencies over a range of 0.1 to 100 Hz. At the end of stimulation, current is decreased in a ramp-like fashion over 10s from 2mA to 0mA. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction
Other Name: trns




Primary Outcome Measures :
  1. Reduction in Total Score of the Auditory Hallucinations Rating Scale [ Time Frame: At 1 week and 1 month post treatment. ]

Secondary Outcome Measures :
  1. Safety and Tolerability of Treatment Based on the Stimulation Side Effect Questionnaire [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  • Age 18 to 64
  • Experiencing medication refractory auditory hallucinations
  • No antipsychotic medication changes or hospitalizations in the previous 4 weeks
  • No substance dependence in the past six months and no substance abuse in the past month
  • No clinically significant head injury or neurological disease
  • Sufficient spoken English so as to be able to comprehend testing procedures
  • No diagnosis of mental retardation or pervasive developmental disorder, i.e. premorbid IQ not less than 70
  • Ability to give informed consent

Exclusion Criteria

  • History of seizures or epilepsy
  • History of metallic cranial plates, screws, or implanted device
  • History of craniotomy
  • History of eczema on the scalp
  • Diagnosis of bipolar disorder
  • Diagnosis of major depression with psychotic features
  • Unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715765


Contacts
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Contact: Brent G Nelson, MD 952-525-4529 nels1741@umn.edu

Locations
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United States, Minnesota
5775 Wayzata Blvd Suite 200 Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Brent G Nelson, MD    952-525-4500      
Principal Investigator: Brent G Nelson, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Minneapolis Veterans Affairs Medical Center

Publications:

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02715765     History of Changes
Other Study ID Numbers: 1512M81581
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Schizophrenia
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms