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March 33, 1972

Julian It. Laoky,
ﬁational Institute of'obntal Boalth
PEAK}.

ﬂockville,

234m land

Eef: mom

M23158~01

Dear Jack,

While the propocal, "Treatment of'Schiaophrenia by
important and interesting goals, the methods are

EU?" has

Regressive
inadequate to

it

tile?

wish. to encourage such
tho invoctigatom to discuss

task. Shoula tho Comrlttoo

for
a program,
'tao loouoo with others: tho lntorrolationo of’modiflcations of‘tﬁe
EC? process to thorapoutlc outcome, and the ioauos in quantifloatlon
of the EEG. In addition, since the twin leouoo in rogrosoivo 3326‘? from
a publéo health point of'olow are the long torn offocto of‘multlple
ooizuroe, coon as an assault on the oontral nervous syctong particularly
on matures of brain function and on ouch capacities as concorztmt’lon,
momory, and thought processes, the evaluation of‘nourological doflcéts
and paychologicol tosto fbouoaod ow what to usually called 'organiolty’
must be conoldored.
would be adviecdalo

The investigators have done an
of'rcgrocoioe EC? in schizophrenic patients.

interesting clinical study
There to a mood for such

a ro~ovaluatlon of’rogroaaivo ﬁll; for thin modification has a chequered
rarely useful. Recent otudloa of’multlple
history. Oldor studies found
Elf; undor omygonatlon control, have indicatod that multiple ECT ans

it

dofloito, or EEG
soft, producing no moro momory loss, neurological ECT
only occasionally
changes than single ECT. Unfortunately, multiple
produces bettor results than single EST in doproeood patients. The data
for schizophrenic patients is unclear, holevor; and thorn now are some
roports of'bottar results with multiple ECT. Those data require vorifloation, and in this framowork, the proposal by Ewnar warrants some

aselstanoo.1h its prooont form, it is inodbquate to the tasks outlined
by the investigators, and suggested by my view of the public health ioauoa.
5%:

favorable foaturos of the proposal:

1) the population is adequate, and the setting to probably a good one for
such studies. (1h our investigations of ECT at Gracia Square and Hillside,
was in those small hospitals that tho staff’wore favorably diaposod tp

it

Elf; allowing tho inventigationa to proceed.)
2)

Tﬁo

investigatora

have an

interact and

coma

experience in regressive

ECT.

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March 23’ 1972

sahibits statistical and design sophistication, and his

rocord as psychometrist

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is

good.

"7”,

The

negative features of the proposal:

1) The design is EDT vs. drug treatment. Ihie
the design to be followed,
issue, but were

it

is not the

most important

there are specific problems.

While the evaluation methods may be adequate indices of
2)
change in personality and behavior, the issue in gegressive ECT is the
impact on interpersonal behavior, neurological deficits, thought
processes, memory, and concentration. In their first study, they
emphasise a persistence of’some of the thought disorder—- but is
and how is
changed ? The clinical aspects seem inadsquately
it different
covered, and the emphasis on a psychiatric interview no less than 30
minutes and no more than 45 minutes is mechanistic and less than helpful.

it

,

ihe EEG evaluation is at thewwrong time for any important
issue. Perhaps the EEG should be evaluated soriatim (weekly) to assess
the rate and degree of change in brain function. But most critical
is the likelihood that the patients will all receive drugs after the
treatment course. The druggcontrols of‘neeeseity; the EC? patients
most probably. Since no statement is Mada about the specific drugs,
dosages, and relation of.EEG measures to drug intake, I have to assume
the investigators are not acutely aware of the impact of drugs on the
536. To unravel EEG effects of BCT from drugs without attention to
the controls necessary, is exceedingly dijyicult.
Zhe same problem in the evaluation and followvup will
occur for other indicss»~ what is the impact of'drugs given after
regressive EC? on the EC? process, and on the comparison of ECT and
drugs ? (For this reason, I would favor regressive ECT vs single ECT).

3)
Patient selection is an issue. The statement of'proceee
schizophrenia is inadequate. The tests described are too non~specific
to help others define the population. It were better for the investigators
to specify which criteria of'process schizophrenia they use (3.9. Fish,
ﬂuylor, others ?). Psychological tests are supplementary~~ they cannot
be used as the diagnostic criteria.

criteria

While

I

am

not ordinarity prone to question selection

ethical grounds, in this instance, the authors should be
asked to make clear some of their minimum criteria of'prior treatmonts
and failure, recent treatmont and failure, etc. before regressive ECT.
Should not all patients have had a course of 'regular' ECT and failed ?
4)
Psychological tests are given heavy emphasis, but the
theoretic base from which these tests more selected is not indicated.
Why the MMPI and the SPEC ? Neither is sufficiently specific in its
interpretation to be very helpful.
on

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23’ 1972

There are many problems with the EEG measures, but since
I)
the study could be done without EEG measures, I will not go into full
detail of’theinadequacies. It is not clear why the investigators are
measuring EEG effects, for the only specific suggestion comes from the
description of lack of’abnormality before and after treatment, as

evaluated by the neurologists on visual inspection. Ihe issues
that could be investigated are the differences in EEG effects of
regressive ECT vs other Elﬂk the rate at which the induced changes
disappear; the relation of change to improvement, to memory ef?ects,
or to other neurological indicee.

They suggest quantification of'the EEG; suggesting
recording and analysis for short epochs. The equipment they
request, representing a large part of'the budget, is adequate only for
the analog to digital convereion, and some simple steps of'data reduction.
But EEG data ie voluminous, even when reduced, and the interrelations
among many channels a horrendous task. (Indeed, very few investigators
have challenged more than one or 2 channel data, and if'more, only for
1 0r 2 minute epoche).
3 channel

To

is

Their interest in sleep

EEG

is unjustified in the protocol.

eben suggest cloep EEG recording (3 hours), for 8 channels (1),
so voluminous a tack, tiat I suspect they do not mean this. gheir

suggestion about.doing visual analysis of the sleep records is
interesting, but thie too it a big tack, and will not in their
few cases, answer any of the auctions. She came problem of drug
control must be considered here.
#-

10

d

J!

.Ez.reureading this proposal, I believe the investigator
brings to the questions, posed by his clinical colleagues, and experience
as a clinical psychologist and psychometrician. fhese aspects seem well
handled. For 'eeientific' reasons and interests, they are suggesting
EEG analyses, sleep recording, and some follow~up studies. In these
aspects, they seem to lack experience, but also sufficient judgment to
visualize the taske and to obtain advice. Perhaps, were they encouraged
to visit and'worh ith one of the university based centers studying
ECT and one focussed on quantification of the EEG, these issues might
become clearer to them. were they then still interested in the studies
suggested here, a better proposal might (?) be forthcoming.

Alternatively, the design could be reduced to a clinical
replication of their pilot study, with some better statement of'the
population, assessment of’neurologioal effects, control of EC? parameters
and drugs, etc.—- and a contribution made to the EC? literature. In the
latter case, the budget could be subjected to reworking, deleting
sleep and statistical consultants ($3800), equipment ($20,500), and
EEG chart paper ($600); with additions for neurological evaluation.
helpful. Iou already know the
I trust those comments are
these
laboratories
in
interested
issues, and I am confident
principal
that any would be interested in this study.
’ISincerely yours,
Mam

Fink, M.D.

.

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