NCT01072617

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

June 5, 2017

Completed
Last Updated

June 5, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

February 19, 2010

Results QC Date

January 20, 2017

Last Update Submit

April 28, 2017

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    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.

    3 weeks

Secondary Outcomes (3)

  • Positive and Negative Syndrome Scale (PANSS) - Positive Subscale

    Baseline, 5 days (post-treatment), 1 week post treatment

  • Positive and Negative Syndrome Scale (PANSS) - Negative Subscale

    Baseline, 5 days (post-treatment), 1 week post treatment

  • Positive and Negative Syndrome Scale (PANSS) - General Subscale

    Baseline, 5 days (post-treatment), 1 week post treatment

Study Arms (1)

Safety of rTMS in schizophrenia patients

EXPERIMENTAL

Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days

Device: Transcranial magnetic stimulation via MagPro x100 device

Interventions

Transcranial magnetic stimulation via MagPro x100 deviceDEVICE

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.

Safety of rTMS in schizophrenia patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Alvaro Pascual-Leone
Organization
BIDMC
apleone@bidmc.harvard.edu
617-667-0203

Study Officials

  • Alvaro Pascual-Leone, MD, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

February 19, 2010

First Posted

February 22, 2010

Study Start

February 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

June 5, 2017

Results First Posted

June 5, 2017

Record last verified: 2017-04

Locations

US(1)