The Use of Transcranial Electrical Stimulation for Hallucinations

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

Interventions

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

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

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

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center

  collaborator FED

• University of Minnesota

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• United States

Study Locations