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                  <text>~¢ w

Julian

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Dear Jack,

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EXHER

M323152~01

AM lo the proposal, ”Malamute of Schizophrenia by
E .3" has imartmt and interesting goals, the methods

".7,me

wuw—

-

March 23, 1972

E. Laoky, Phi).

Hational Institute of’Mhntal Hoalth
Bookv’llle, daryland

.
.

wvw-va,

Regressive
are
inadequate to tho task. Should ﬁlm Committee wish to encourage such
a program, it would lo advisable for the investigators to diamos
two isouao with otz‘zoro: tho lrztomlatimzo of modifications of the
363‘ prooeoa to therapeutic outcome, and the; isouaa in quantification
of the EEG. In Million, since the min «Issues in regrosoivo EC'T from
a public hoalth point of view are the long Mm affects of multiple
seen as an aaeault on the central nervouo amt-om, particularly
“lama,
on masuree of brain Motion and on such oapaoitloa as concentration,
mmry, and thought prooooaoa, the evaluation of nouroZOgloal deficits
and poyoizologéoal taste focusoad on what is usually called ’organioity’
must be considered.

“.I-vv‘wrrnr—y

investigators have done an interns ting clinical study
in oohiaophranio patients. There is a need for such
a ra-evaluatt‘on of regressive 3‘02”, for this modification has a chequered
history. Older atudiee fomd it rarely useful. Recent studies of multiple

of mgroealve
‘

,
am

mzwwnmvvvmwmw

«A;

A-"ﬁz'sv

362’,

The

EC?“

under oxygenation control,- kave indt'oatod

safe, pmduaing no

that multiple

ECT

are

mmry lose, nomlogioal deficits, or EEG
changes than slnglo E63". Unfortunately, multiple E02” only occasionally
produces better results than Mingle ECT in depressed patients. Tho data
for schizophrenic patients is unclear, hmwr; and than now are some
reports of better results: with multiple E’CT. Thaw data mantra verthe proposal 2):; Row:- warrmta some
ification, and in this
assistcmann its present form, it is inadequate to the make outlined
by the investigators, and suggostod by my view of the public health issues.
more

erk,

favorable features of the proposal:
is adequate, and the setting is probably a good one for
such studios. (In our investigations of ECT at Gracie Square and Hillside,
was in those small hospitals that the staff were favorably diaposed tp
it
EST, allowing the investigations to proceed.)
The

1) the population

2) The investigators have an

interest and

some

experience in rograsaiva

EC’T.

�EXNE’HOOIOIIOOIOCOOOOODCOIOOIOOQII

2.0.00.00090000. We}: 33’

1972

3} 2%3 PI ochibits statistical and doeign sophistication, and his
rocord as pcychomotrist is good.

Iﬁo negative fhaturoc

of'tho proposal:

1) The aeaign is ECT vs. drug treatmont. This £8 not the most important
locus, but were it the doslgn to be followed, there are specific problemc.

2)

change

Wﬁile the evaluation mothodc may be adoquato lndicoc

in porconallty and behavior, the issue in gogroacivo

ECT

of

is the

impact on lntorporoonal behavior, neurological dcflcltc, thought
processes, momory, and cmontraoion. In their first study, they
emphasize a porcictonce of’somo of’tho thought disordcr~u but is
it difforont and how is changed ? The clinical aspects seem inadbquatcly
covered, and the omphaois on a psychiatric interview no less than 30
mdnuteo and no more than 45 minutoo is mochaniotic and loos than helpful.

it

ovaluction is at thoworong time for any important
ghoulﬁ be evaluated coriatlm (weekly) to assess
tho rate and dogroo of’chango in brain function. But wool critical
is the likolikood that the patiouts will all rooeivc drugs aflor the
treaomont oourso. Yﬁo druggcontrolc of'nocoocity; the EC? patients
most probably. Slﬁoo no statcmont is modo about the specific drugs,
dosages, and relation of EEG measuroa to drug intako, I have to asaumo
the investigators are not acutely awaro of'thc impact of'drugs on the
EEG. To unravol EEG effocts of ECT from drugs without attention to
the controls necessary, is exceedingly dlfflcult.
Iﬁo

EEG

issue. Porhaps the

EEG

fﬁe samo problem in the evaluation and followmup will
what {a the impaco of’drugc given after
EU?
tho
EC?
on
rogroacivo
prococc, and on the compariaoo of'ECT and
drugo 7 (For thio reason, I would favor rogrosolvo ECT vs single ECT).

occur for other indicoc~~

Patient selection is

3)

XII-Mr.

,

an

issue.

The statement of’procoas
doccribad are too nan~spcciflc

schizophrenia is inadoquato.
tests
to help othera define tho population. It were better for the investigators
to specify which criteria of’prococc schizophrenia thoy use (3.9. Fish,
Eoylor, others ?). Paychological tests are supplementary~~ they cannot
be used as the diagnostic critcria.
Too

criteria

on

while I'am not ordlnarily prone to question selection
ethical groundb, in this instance, the authors should be

asked to make clear aomo of'thcir minimum criteria of’prior treatments
and failure, recent treatmont and failure, etc. bcfbro rogrcssivo ECT.
Should not all pationtc have had a course of”rcgu&amp;ar' ECT and failed ?

Poychological teats arc given heavy emphasis, but the
more selected in not indicated.
Why the MMPI and the SRSC ? Noithcr is aulecicntly speciflc in its
interpretation to be very helpful.
4)

theoretlc bass from which these touts

�EXNEktiioﬁioIOODOOOOOCDIOOIOOOCO

3

OUOIOQCOOOOOCO‘IOIOOWh

I)

There are many problcma with the
the ctudy could be done without EEC moaaurcc,

EEG

33’ 1972

measures, but cincc

I will not

go

into full

datail of’thcinadbquaciac. It to not clcar why the invcctigatorc are
measuring E33 affccte, for the only specific suggestion comoc from the

dhscriptéon of’lack of’abncrmallty bcfbro and after troatmont, as
evaluated by tho neurologists on visual lncpcction. Etc issues
that could be investigated are the difycrancca in EEG offhctc of
rogroscivc EU? to other EZﬂk the rate at which the induced changes
disappear; the relation of‘changa to improvement, to memory cffhctc,
or to other neurological indlccc.

They cuggcat quantiftcation cf'thc Eﬁﬂg suggesting
rocording and analysis for chart epochs. Tﬁc equipmont they
request, rcprccenttng a large part of'thc budget, to adoquatc only for
the analog to digital conversion, and some simplc ctcpc of'data reduction.
But EEG data it voluminous, coon when reduced, and the interrelations
among many chancclc a horrcndouc tack. (Ihdocd, vary for investigators
have challenged more than one or 2 channel data, and tf’morc, only for
1 0r 2 minute cpochc).
8 channel

Their interest in sleep EEG to unjustified in the protocol.
cbcn suggest sleep EEG recording (8 hours), for 8 channels (I),
to so voluminous a tack, tkat I cucocct tlcy do not moan this.
suggestion about doing visual analytic of'tha sloop records to
interacting, but this too to a big task) and will not in thctr
for cares, answer any of’tka quattcac. The same problem of'drug
control must be considorcd hero.
Eb

thir

I

10

l

4

1h rcwrcadﬁng thic proposal, I believe the investigator
bringo to the questions, posed by his clinical colleagues, and cxpcrlcncc
at a clinical psychologist and psychometrtctan. Those aopcctc scam well
handled. For ’ccicntlfic' reasons and interacts, they are suggesting
EEG analyses, sleep recording, and some fblloa~up studies. It these
aspects, they team to lack experience, but alco cuffictcnt judgmont to
visualize the tasks and to obtain advice. Earhapt, more they encouraged
to visit and work with one of'thc untoercity based centers studying
EC? and on: focuccad on quantification of’thc EZEQ these issues might
become clearer to them. ware they then still interacted in the studies
auggoatcd here, a better propoaal might (?) to fbrtkcomtng.

to a clinical
better atatamcnt of the
population, assessment of'ncurologtcal chhcto, control of'ECT paramctarc
and drugc, ctc.~« and a contribution madc to the EC? literature. In the
Alternatively, the dcctgn could

replication of their pilot study, with

some

be reduced

latter case, the budget could to subjected to rcqorktng; dblcting
sleep and statistical consultants ($8300), equipment ($30,300), and

E36

chart paper ($600); with additions for neurological evaluation.

I trust those comments are helpful. you already know the
laboratories
interacted in those iccuac, and I am confldont
principal
that any would be interested in this study.
Stnccroly yours,
Max

Fink,

MI

D.

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