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Completed

NCT Number: NCT01072617

Cerebellar rTMS for the Treatment of Schizophrenic Patients

The primary aim of this protocol is to determine whether the use of repetitive transcranial magnetic stimulation (rTMS) over vermis of the cerebellum may be safe and therapeutically effective in patients with schizophrenia. Because this is the first evaluation of this treatment in this population, the focus of this study is safety.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-65 years
  • Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)

Exclusion criteria

  • Prior neurosurgical procedures
  • Any history of seizure
  • Previous head injury
  • Contraindication to TMS:
  • Implanted pacemaker
  • Medication pump
  • Vagal stimulator
  • Deep brain stimulator
  • Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
  • Signs of increased intracranial pressure
  • TENS unit and ventriculo-peritoneal shunt
  • Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
  • Advanced liver, kidney, cardiac, or pulmonary disease as defined clinically or a terminal medical diagnosis consistent with survival < 1 year
  • A history of significant alcohol or drug abuse in the prior six months
  • No focal cortical insult can be present, including tumor or vascular malformation
  • Patients may not be actively enrolled in a separate intervention study
  • Patients unable to undergo a brain MR:

a. claustrophobia refractory to anxiolytics ferromagnetic metal in the body such as a prosthetic heart valve, a pacemaker, or a brain aneurysm clip).

  • Change in antipsychotic medication during the last 4 weeks
  • Any emergency psychiatry department visit during the last 4 weeks
  • Been an inpatient in a psychiatry clinic within the last month
  • Any other axis I diagnosis

Treatment and study plan

Transcranial magnetic stimulation via MagPro x100 device

Device

Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.

Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.

Primary outcomes

  1. Adverse Events

    Time frame: 3 weeks

    Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.

Secondary outcomes

  1. Positive and Negative Syndrome Scale (PANSS) - Positive Subscale

    Time frame: Baseline, 5 days (post-treatment), 1 week post treatment

    Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.

  2. Positive and Negative Syndrome Scale (PANSS) - Negative Subscale

    Time frame: Baseline, 5 days (post-treatment), 1 week post treatment

    Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.

  3. Positive and Negative Syndrome Scale (PANSS) - General Subscale

    Time frame: Baseline, 5 days (post-treatment), 1 week post treatment

    Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2010
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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