NCT03544333

Boost rTMS for Auditory Verbal Hallucinations

Terminated NA Results posted Last updated 5 May 2021

What this trial tests

NA trial testing transcranial magnetic stimulation in Schizophrenia in 5 participants. Terminated before completion.

Timeline

16 April 2018

Primary endpoint
22 January 2019

22 January 2019

Quick facts

Lead sponsor	Northwell Health
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	5
Start date	16 April 2018
Primary completion	22 January 2019
Estimated completion	22 January 2019
Sites	1 location across United States

Drugs / interventions tested

• transcranial magnetic stimulation — full drug profile →

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Auditory Hallucination — all drugs for Auditory Hallucination →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 18 to 65, any sex, with Schizophrenia or Auditory Hallucination. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Efficacy of Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations Assessed With the Hallucination Change Scale Primary · Four timepoints of the Hallucination Change Scale (after every TMS session). Here, score after final session is reported.

Examine change in AVH severity, measured with the Hallucination Change Scale, due to low-frequency rTMS. The Hallucination Change Scale is a self-rating assesses severity of hallucinations. It is anchored at baseline using the patient's description of AVH for the previous 24-hours which is assigned a score of 10. The subsequent assessments are in relation to the baseline where a reduction of AVH relates to a value \< 10 (best being a value of 0) and a worsening of AVH relates to a value \> 10 (twice as severe as baseline being a value of 20).

Group	Value	95% CI
Real Transcranial Magnetic Stimulation	15	15 – 15
Sham Transcranial Magnetic Stimulation	7.5	5 – 10

Sponsor's own description

This is a randomized, placebo controlled, double-blind clinical trial. The investigators aim to examine the safety and efficacy of repeated transcranial magnetic stimulation (rTMS) for the treatment of auditory verbal hallucinations (AVH) in patients with schizophrenia who are not taking antipsychotic medication. The investigators employ a novel, accelerated protocol with only four sessions of low-frequency rTMS in one day. The effects of this accelerated protocol will be compared to the sham stimulation. Additionally, the investigators will examine the effects of rTMS on a neurophysiological level by evaluating mechanism of action in the temporo-parietal lobe by means of functional magnetic resonance imaging.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.