The Use of Transcranial Electrical Stimulation for Hallucinations

NCT02715765 | Terminated Results

• 1 other identifier: PSYCH-2016-24233
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Reduction in Total Score of the Auditory Hallucinations Rating Scale

  At 1 week and 1 month post treatment.

Secondary Outcomes (1)

• Safety and Tolerability of Treatment Based on the Stimulation Side Effect Questionnaire

  1 week

Study Arms (3)

Sham

SHAM COMPARATOR

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

Active tDCS

EXPERIMENTAL

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

Active tRNS

EXPERIMENTAL

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

Interventions

Transcranial Direct Current Stimulation DEVICE

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

Also known as: tdcs

Active tDCS

Transcranial Random Noise Stimulation DEVICE

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

Also known as: trns

Active tRNS

Transcranial Sham Stimulation DEVICE

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

Also known as: sham

Sham

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (1)

5775 Wayzata Blvd Suite 200

Saint Louis Park, Minnesota, 55416, United States

Location

Related Publications (7)

• Carter DM, Mackinnon A, Howard S, Zeegers T, Copolov DL. The development and reliability of the Mental Health Research Institute Unusual Perceptions Schedule (MUPS): an instrument to record auditory hallucinatory experience. Schizophr Res. 1995 Aug 1;16(2):157-65. doi: 10.1016/0920-9964(94)00069-k.

  PMID: 7577769 BACKGROUND

• Nitsche MA, Doemkes S, Karakose T, Antal A, Liebetanz D, Lang N, Tergau F, Paulus W. Shaping the effects of transcranial direct current stimulation of the human motor cortex. J Neurophysiol. 2007 Apr;97(4):3109-17. doi: 10.1152/jn.01312.2006. Epub 2007 Jan 24.

  PMID: 17251360 BACKGROUND

• Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.

  PMID: 5146491 BACKGROUND

• Hoffman RE, Hawkins KA, Gueorguieva R, Boutros NN, Rachid F, Carroll K, Krystal JH. Transcranial magnetic stimulation of left temporoparietal cortex and medication-resistant auditory hallucinations. Arch Gen Psychiatry. 2003 Jan;60(1):49-56. doi: 10.1001/archpsyc.60.1.49.

  PMID: 12511172 BACKGROUND

• Lawrie SM, Buechel C, Whalley HC, Frith CD, Friston KJ, Johnstone EC. Reduced frontotemporal functional connectivity in schizophrenia associated with auditory hallucinations. Biol Psychiatry. 2002 Jun 15;51(12):1008-11. doi: 10.1016/s0006-3223(02)01316-1.

  PMID: 12062886 BACKGROUND

• Slotema CW, Aleman A, Daskalakis ZJ, Sommer IE. Meta-analysis of repetitive transcranial magnetic stimulation in the treatment of auditory verbal hallucinations: update and effects after one month. Schizophr Res. 2012 Dec;142(1-3):40-5. doi: 10.1016/j.schres.2012.08.025. Epub 2012 Sep 30.

  PMID: 23031191 BACKGROUND

• Vanneste S, Fregni F, De Ridder D. Head-to-Head Comparison of Transcranial Random Noise Stimulation, Transcranial AC Stimulation, and Transcranial DC Stimulation for Tinnitus. Front Psychiatry. 2013 Dec 18;4:158. doi: 10.3389/fpsyt.2013.00158. eCollection 2013.

  PMID: 24391599 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Kelvin Lim
• Organization: University of Minnesota

kolim@umn.edu

612-273-9803

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 22, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-09

Locations

US (1)