View Clinical Trial (Medical Research Study)
Bilateral rTMS Clinical Trial for Persistent Auditory Hallucinations
| City: |
|
New Haven |
| State: |
|
Connecticut |
| Zip Code: |
|
06519 |
| Conditions: |
|
Schizophrenia |
| Purpose: |
|
This trial is designed to determine if administering repetitive transcranial magnetic
stimulation (rTMS) simultaneously to two sites in the temporal lobes, one on the left and
one on the right, produces greater improvements in "voices" and other symptoms of
schizophrenia compared to rTMS given to just one site in the temporal lobes.
|
| Study Summary: |
|
This study is an extension of an ongoing clinical trial (ClinicalTrials.gov identifier NCT
00308997) that was initiated in 2006. The primary objective of the ongoing clinical trial
(hereafter called the "parent trial") is to determine efficacy of rTMS in curbing auditory
hallucinations when delivered to a part of the left temporal lobe called Wernicke's area and
a corresponding region in the right temporal lobe. The parent trial appears to show robust
effects for active rTMS compared to effects of sham stimulation. However, observed
responses following active rTMS have often been incomplete. Moreover, in some cases there
has been a subsequent return of symptoms 1 to 6 months after the trial ended.
We consequently have initiated a re-enrollment trial where patients who have participated in
the parent trial and demonstrated an incomplete response or a subsequent return of symptoms
may return to receive additional active rTMS. We hypothesize that efficacy of suppressive
rTMS will be enhanced if directed simultaneously to right/left Wernicke's area (the site
used in the parent trial) as well as to a second site located in the opposite middle
temporal cortex. Roughly half of subjects in the re-enrollment will be randomized to receive
active rTMS to right/left Wernicke's area plus active rTMS to opposite hemisphere middle
temporal region, while half of subjects will be randomized to receive active rTMS to
right/left Wernicke's area plus sham rTMS to opposite hemisphere middle temporal region.
The position of the middle temporal regions will be determined by two recently completed
brain imaging studies of auditory hallucinations suggesting that activation in these sites
triggers auditory hallucinations. The two-position design will allow us to determine if
active rTMS delivered to the middle temporal cortex is superior in amplifying efficacy of
active rTMS targeting Wernicke's area and in reducing auditory hallucinations to sham
stimulation to the same site. The re-enrollment protocol will utilize two rTMS devices
simultaneously where one directly triggers the other.
We have added a third arm to the protocol (3/2012) where the same intervention described for
Arm 1 is provided to enrollees, but no randomization or comparison with Arm 2 is pursued.
The primary purpose of this Arm is to conduct fMRI neuroimaging studies prior to and
subsequent to the rTMS intervention. Our intent is to ascertain changes in regional brain
activation and connectivity that most robustly predict level of improvement in auditory
hallucinations elicited by bilateral rTMS as assessed by our primary outcome variables.
This combined fMRI/rTMS study will provide critical new insights into the neurobiological
basis of auditory hallucinations.
|
| Criteria: |
|
Inclusion Criteria:
- Previously enrolled in our "parent" rTMS trial with passage of at least six months
since last received active rTMS
Exclusion Criteria:
- Active substance abuse or alcohol abuse
- Pregnancy
- Dose or type of psychiatric medication changed within the 4 weeks prior to study
entry
- Recent head trauma, seizures, or significant unstable medical condition
|
| NCT ID: |
|
NCT00567281 |
| Primary Contact: |
|
Principal Investigator
Ralph Hoffman, MD
Yale University
Petra Kleinlein, PhD
Phone: 203-785-7918
|
| Backup Contact: |
|
Email: ralph.hoffman@yale.edu
Ralph Hoffman, MD
Phone: 203-688-9734
|
| Location Contact: |
|
New Haven, Connecticut 06519
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 20, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|